AccessGUDID - DEVICE: Platelet Wash and Storage Solution (10888234000488)

GUDID

Device Identifier (DI) Information

Brand Name: Platelet Wash and Storage Solution
Version or Model: 0005035
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 0005035
Company Name: IMMUCOR, INC.

Primary DI Number: 10888234000488
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 061446282 *Terms of Use

Device Description: Platelet Wash and Storage Solution (PWSS) is used to wash, suspend and store platelets. The solution is provided in a 1 liter bag.

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?
47125	Platelet storage solution	A fluid used to partially replace plasma in the preparation and storage of buffy coat-derived platelet concentrates or apheresis platelet units. It typically includes several compounds [e.g., sodium chloride (NaCl), sodium citrate (Na3-citrate), potassium chloride (KCl), magnesium chloride (MgCl2)] to maintain optimal pH and minimize platelet aggregation at room temperature. It is supplied in a container (e.g., a polypropylene bag) and is not for direct intravenous (IV) infusion. This is single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KSS	Supplies, Blood-Bank

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
BK880015	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: 18845d09-6007-4991-8b81-779a6516a34b
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: April 14, 2016