AccessGUDID - DEVICE: Gamma PeG (10888234001782)

GUDID

Device Identifier (DI) Information

Brand Name: Gamma PeG
Version or Model: 0705003
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 0705003
Company Name: IMMUCOR, INC.

Primary DI Number: 10888234001782
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 061446282 *Terms of Use

Device Description: Gamma PeG is used an additive to enhance reactivity in the detection of unexpected blood group antibodies. This product is Polyethylene Glycol (PeG) in a low ionic strength saline solution, and is the three (3) vial configuration.

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):	Yes
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
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?
52730	Polyethylene glycol (PEG) immunohaematology reagent IVD	A substance or reactant that is a polyethylene glycol (PEG) solution, intended to be used in immunohaematological testing of a clinical specimen to enhance or potentiate agglutination reactions by reducing the zeta potential of red blood cells.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KSG	Media, Potentiating For In Vitro Diagnostic Use

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
BK910001	0

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 1 and 10 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 9a3a438a-38ac-4907-957b-8b18584054f3
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: April 15, 2016