AccessGUDID - DEVICE: Cartridge Blood Set (07332414112400)

GUDID

Device Identifier (DI) Information

Brand Name: Cartridge Blood Set
Version or Model: 114435
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 114435
Company Name: Gambro Renal Products, S.A. de C.V.

Primary DI Number: 07332414112400
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 812560399 *Terms of Use

Device Description: The Gambro Cartridge Blood Set is intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery System from Rev. SW 3.40. The Low Weight - Low Volume model is used when a low extracorporeal blood volume is recommended.

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?
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 [?]
K100364	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
Storage Environment Temperature: between -18 and 49 Degrees Celsius
Storage Environment Temperature: between 0 and 120 Degrees Fahrenheit
Special Storage Condition, Specify: The blood transport system must be stored in a dry place

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f9d5b312-8625-4bb9-8f31-bf4939ee75a2
Public Version Date: March 25, 2024
Public Version Number: 7
DI Record Publish Date: October 23, 2015