AccessGUDID - DEVICE: W.A.R.M. (10888234001010)

GUDID

Device Identifier (DI) Information

Brand Name: W.A.R.M.
Version or Model: 0057319
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 0057319
Company Name: IMMUCOR, INC.

Primary DI Number: 10888234001010
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 061446282 *Terms of Use

Device Description: W.A.R.M. (Warm Autoantibody Removal Medium) is used for the removal of warm-reactive autoantibody from red blood cells to facilitate resolution of serological complexities. W.A.R.M. is a specially formulated preparation of dithiothreitol and cysteine-activated papain in a phosphate buffer. It has been filtered and lyophilized. This product must be reconstituted with deionized water and mixed thoroughly prior to use. The product configuration is ten (10) vials.

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:	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?
52728	Papain immunohaematology reagent IVD	A substance or reactant that is a papain enzyme solution intended to be used in immunohaematological testing of a clinical specimen to enhance or potentiate red cell agglutination reactions by enzymatically digesting red cell membrane proteins and removing sialic acid residues.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KSK	Solution, Stabilized Enzyme

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
BK830008	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: 87029884-80ed-477a-a397-63ba7170f6a5
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: April 18, 2016