AccessGUDID - DEVICE: Fisherbrand (00613647000816)

GUDID

Device Identifier (DI) Information

Brand Name: Fisherbrand
Version or Model: 401025FB
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 401025FB
Company Name: FISHER SCIENTIFIC COMPANY L.L.C.

Primary DI Number: 00613647000816
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 24
Labeler D-U-N-S® Number*: 004321519 *Terms of Use

Device Description: Glucose Tolerance Beverage 75G LEM NC PLAS FB 24/CS

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):	Yes
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?
53307	Glucose IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of glucose in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MRV	DRINK, GLUCOSE TOLERANCE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K032753	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6805b573-0463-4b4e-a0ce-58ed0ba0d137
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 24, 2016