AccessGUDID - DEVICE: Transfer Pack (10811137010551)

GUDID

Device Identifier (DI) Information

Brand Name: Transfer Pack
Version or Model: 4R2024
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 4R2024
Company Name: FENWAL, INC.

Primary DI Number: 10811137010551
Issuing Agency: GS1
Commercial Distribution End Date: February 11, 2019
Device Count: 12
Labeler D-U-N-S® Number*: 794519020 *Terms of Use

Device Description: Transfer Pack Container 600 mL with Male Luer Adapter. Sterile Fluid Path

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?
44904	Blood/tissue storage/culture container	A receptacle intended for the storage and/or culture of tissue, cells, blood or blood components (e.g., peripheral blood stem cells) typically for subsequent therapeutic applications. It has a variety of shapes and sizes, may reduce the risk of contamination, may be used during freezing, and may be gas permeable. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KSR	Container, Empty, For Collection & Processing Of Blood & Blood Components

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: Yes
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: b00887a9-1282-4236-bd45-0474734dbfc7
Public Version Date: June 17, 2022
Public Version Number: 4
DI Record Publish Date: September 12, 2016