AccessGUDID - DEVICE: Di(a+) Cell (10888234000471)

GUDID

Device Identifier (DI) Information

Brand Name: Di(a+) Cell
Version or Model: 0005021
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 0005021
Company Name: IMMUCOR, INC.

Primary DI Number: 10888234000471
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 061446282 *Terms of Use

Device Description: Di(a+) Cell is used in the detection of unexpected red blood cell blood group antibodies. Di(a+) Cell is a single vial of group O, Di(a+) red blood cells.

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:	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):

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
61232	Di^a positive reagent red blood cell IVD, antigen	A sample of specifically characterized reagent red blood cells intended to be used in testing a clinical specimen due to their classification as Di^a positive. These reagent cells are positive for the Diego blood group antigen Di^a [DI001].	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
No Product Codes

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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: c8967086-a8d0-4cbd-b0dc-822eb53e984a
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: October 30, 2014