International Medical Devices Database

Manufacturer Address
Polymedco, Inc, 510 Furnace Dock Rd, Cortlandt Manor NY 10567-6220
Manufacturer Parent Company (2017)
Polymedco Inc.
Source
USFDA
2 Events
- Recall of Device Recall OC Light Manual iFOBT strips
- Recall of Device Recall OC Light Manual iFOBT strips

2 devices in the database

Device Recall OC Light Manual iFOBT strips

Model / Serial
Kit Lot # P207830 - Kit Expiration Date 2/28/2013 - Test Strip Lot # 18005M; Kit Lot # P210191 - Kit Expiration Date 4/30/2013 - Test Strip Lot # 1X009M Kit Lot # P210192 - Kit Expiration Date 4/30/2013 - Test Strip Lot # 1X010M; Kit Lot # P217033 - Kit Expiration Date 5/31/2013 - Test Strip Lot # 1Y011M; Kit Lot # P217034 - Kit Expiration Date 5/31/2013 - Test Strip Lot # 1Y012M; Kit Lot # P217035 - Kit Expiration Date 6/30/2013 - Test Strip Lot # 1Z013M; Kit Lot # P222808 - Kit Expiration Date 6/30/2013 - Test Strip Lot # 1Z013M.
Product Classification
Hematology and Pathology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution-USA (nationwide) including Puerto Rico, and the countries of Canada and Guam.
Product Description
Test Strips packaged in the OC-Light Manual iFOBT Kit, Catalog No. FOBSTR. || For the rapid, qualitative detection of human hemoglobin in feces.

Device Recall OC Light Manual iFOBT strips

Model / Serial
Kit Lot # P205877 - Kit Expiration Date 2/28/2013 - Test Strip Lot # 18004M; Kit Lot # P210125 - Kit Expiration Date 3/31/2013 - Test Strip Lot # 19006M; Kit Lot # P210204 - Kit Expiration Date 3/31/2013 - Test Strip Lot # 19006M; Kit Lot # P212420 - Kit Expiration Date 4/30/2013 - Test Strip Lot # 1X009M; Kit Lot # P212421 - Kit Expiration Date 4/30/2013 - Test Strip Lot # 1X009M; Kit Lot # P210194 - Kit Expiration Date 4/30/2013 - Test Strip Lot # 1X010M; Kit Lot # P217043 - Kit Expiration Date 5/31/2013 - Test Strip Lot # 1Y012M; Kit Lot # P234499 - Kit Expiration Date 11/30/2013 - Test Strip Lot # 25011M; Kit Lot # P234664 - Kit Expiration Date 11/30/2013 - Test Strip Lot # 26012M; Kit Lot # P238025 - Kit Expiration Date 12/31/2013 - Test Strip Lot # 26012M; Kit Lot # P238028 - Kit Expiration Date 12/31/2013 - Test Strip Lot # 26013M; Kit Lot # P243938 - Kit Expiration Date 12/31/2013 - Test Strip Lot # 26012M.
Product Classification
Hematology and Pathology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution-USA (nationwide) including Puerto Rico, and the countries of Canada and Guam.
Product Description
Test Strips packaged in the OC-Light Manual iFOBT Kit, Catalog No. FOB50. || For the rapid, qualitative detection of human hemoglobin in feces.

One manufacturer with a similar name

Learn more about the data here

Polymedco, Inc

Manufacturer Address
Polymedco, Inc, 510 Furnace Dock Road, Cortlandt Manor NY 10567-6220
Source
USFDA

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Disclaimer

Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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