Freestyle Navigator Continuous Glucose Monitor System

Abbott Item #70684-01; Lot No. 01M0248; Kit Serial numbers BAAH220-80089, BAAH220-81000, Tx Serial Numbers AAAH187-80187, AAAH187-80845.

Clinical Chemistry and Clinical Toxicology Devices

3

No

Worldwide Distribution -- United States (OH, FL, NJ, CA, MS, MN, MA, and NY), France, Australia, the Netherlands, Sweden, the UK, Israel, Ireland and Germany.

Freestyle Navigator Continuous Glucose Monitor System, ART 16467 Rev A, ABB SYSTEM KIT(ORANGE)PACK NAV, Abbott Item Number 70684-01, distributed by Abbott Diabetes Care Inc, Alameda, CA. || Medical device indicated for continually recording interstitial fluid glucose levels in people ages 18+ with diabetes mellitus for improving diabetes management. The device is indicated to be used in hospital and home settings to aid health care.

Abbott Item # 70684-03; with multiple lot numbers, kits serial numbers, and Tx serial numbers. Lot numbers are these: 01M2328 or 01M2388 or 01M2408 or 01M2478 or 01M2528 or 01M2558 or 01M2608 or 01M3518, or 01N0208 or 01N0488 or 02N0068. Kit Serial numbers beginning with: BAAH 067, BAAH 093 or BAAH 107 or BAAH 156 or BAAH 162 or BAAH 186 or BAAH 200 or BAAH 207 or BAAH 220 or BAAH 223 or BAAH 243 or BAAH 261 or BAAH 275 or BAAH 290 or BAAH 275 or BAAH 299 or BAAH 341 or BAAH 353 and followed by a five (5 )digit number. Tx Serial numbers beginning with: AAAH 139 or AAAH 158 or AAAH 195 or AAAH or AAAH 268 or AAAH 296 and followed by a five (5) digit number.

Clinical Chemistry and Clinical Toxicology Devices

3

No

Worldwide Distribution -- United States (OH, FL, NJ, CA, MS, MN, MA, and NY), France, Australia, the Netherlands, Sweden, the UK, Israel, Ireland and Germany.

Freestyle Navigator Continuous Glucose Monitor System, ART 16467 Rev A, SYSTEM KIT PACKAGING , Abbott Item Number 70684-03, distributed by Abbott Diabetes Care Inc, Alameda, CA. || Medical device indicated for continually recording interstitial fluid glucose levels in people ages 18+ with diabetes mellitus for improving diabetes management. The device is indicated to be used in hospital and home settings to aid health care.

Abbott Item # 70791-01; with multiple lot numbers, kits serial numbers, and Tx serial numbers. Lot numbers are these: 01M1928, 01M1978, 01M2038, 01M2178, 01M2528, and 01M3258. Kit Serial numbers beginning with: AAAH 090 or AAAH 139 or AAAH 158 or AAAH 187 or AAAH 195 or AAAH 268 or AAAH283 and followed by a five (5 )digit number. Tx Serial numbers beginning with: AAAH 090 or AAAH 139 or AAAH 158 or AAAH 187 or AAAH 195 or AAAH 268 or AAAH 283 and followed by a five (5) digit number.

Clinical Chemistry and Clinical Toxicology Devices

3

No

Worldwide Distribution -- United States (OH, FL, NJ, CA, MS, MN, MA, and NY), France, Australia, the Netherlands, Sweden, the UK, Israel, Ireland and Germany.

Freestyle Navigator Continuous Glucose Monitor System, ART 16467 Rev A, ABB Warranty Kit Xmitter Nav, Abbott Item Number 70791-01, distributed by Abbott Diabetes Care Inc, Alameda, CA. || Medical device indicated for continually recording interstitial fluid glucose levels in people ages 18+ with diabetes mellitus for improving diabetes management. The device is indicated to be used in hospital and home settings to aid health care.

Abbott Item # 70791-02; with multiple lot numbers, kits serial numbers, and Tx serial numbers. Lot numbers are these: 01M2068, 01M2548, and 01M3238.  Kit Serial numbers beginning with: AAAH 187 or AAAH 195 or AAAH283 and followed by a five (5 )digit number. Tx Serial numbers beginning with: AAAH 195 or AAAH 283 and followed by a five (5) digit number.

Clinical Chemistry and Clinical Toxicology Devices

3

No

Worldwide Distribution -- United States (OH, FL, NJ, CA, MS, MN, MA, and NY), France, Australia, the Netherlands, Sweden, the UK, Israel, Ireland and Germany.

Freestyle Navigator Continuous Glucose Monitor System, ART 16467 Rev A, Replacement Kit, Transmitter, Abbott Item Number 70791-02, distributed by Abbott Diabetes Care Inc, Alameda, CA. || Medical device indicated for continually recording interstitial fluid glucose levels in people ages 18+ with diabetes mellitus for improving diabetes management. The device is indicated to be used in hospital and home settings to aid health care.

Abbott Item # 70791-20; with multiple lot numbers, kits serial numbers, and Tx serial numbers. Lot numbers are these: 01N0578, 02N0418 and 04N0418     Kit Serial numbers beginning with: AAAH 187 or AAAH 195 or AAAH283 and followed by a five (5 )digit number. Tx Serial numbers beginning with: AAAH 195 or AAAH 283 and followed by a five (5) digit number.

Clinical Chemistry and Clinical Toxicology Devices

3

No

Worldwide Distribution -- United States (OH, FL, NJ, CA, MS, MN, MA, and NY), France, Australia, the Netherlands, Sweden, the UK, Israel, Ireland and Germany.

Freestyle Navigator Continuous Glucose Monitor System, ART 16467 Rev A, Reorder/Warranty Kit EMEA, Abbott Item Number 70791-20, distributed by Abbott Diabetes Care Inc, Alameda, CA. || Medical device indicated for continually recording interstitial fluid glucose levels in people ages 18+ with diabetes mellitus for improving diabetes management. The device is indicated to be used in hospital and home settings to aid health care.