AccessGUDID - DEVICE: Fresenius (10840861100535)

GUDID

Device Identifier (DI) Information

Brand Name: Fresenius
Version or Model: 04-9300-7
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 04-9300-7
Company Name: Fresenius Medical Care Holdings, Inc.

Primary DI Number: 10840861100535
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 958291411 *Terms of Use

Device Description: Prime Bags, 2-Liter, bulk pack

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):	No
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?
34999	Haemodialysis blood tubing set, single-use	A collection of tubing segments and associated devices (e.g., connectors, clamps) intended to be used to transfer blood between a patient's vascular access device and a haemodialyser during haemodialysis; it is sometimes referred to as haemodialysis blood lines. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FJK	SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K962081	000

Device Exempt from Premarket Submission: No 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
Total Volume: 2 Liter

Device Record Status

Public Device Record Key: 2bafb0a1-001c-4f8f-93c8-127f655352a7
Public Version Date: June 07, 2019
Public Version Number: 4
DI Record Publish Date: September 30, 2015