AccessGUDID - DEVICE: OC-Light (00855574005070)

GUDID

Device Identifier (DI) Information

Brand Name: OC-Light
Version or Model: FOBBTL
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC

Primary DI Number: 00855574005070
Issuing Agency: GS1
Commercial Distribution End Date: June 30, 2017
Device Count: 1
Labeler D-U-N-S® Number*: 078413594 *Terms of Use

Device Description: Sampling Bottles OC-Light

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
54532	Faecal occult blood IVD, kit, rapid ICT, clinical	A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative screening of stool (faeces) for occult blood (haemoglobin and/or transferrin) within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KHE	Reagent, Occult Blood

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K041297	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 2 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0f58b559-6c9c-43db-8a6b-082dda8ff8eb
Public Version Date: July 17, 2023
Public Version Number: 6
DI Record Publish Date: September 23, 2016