AccessGUDID - DEVICE: Adsorba Hemoperfusion cartridge (07332414015480)

GUDID

Device Identifier (DI) Information

Brand Name: Adsorba Hemoperfusion cartridge
Version or Model: 150C
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 101097
Company Name: Gambro Dialysatoren GmbH

Primary DI Number: 07332414015480
Issuing Agency: GS1
Commercial Distribution End Date: May 11, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 316150549 *Terms of Use

Device Description: The Adsorba 150C hemoperfusion cartridge is a steam sterilized device which contains 150 grams of cellulose-coated activated charcoal. The device is filled with physiological saline solution prior to sterilization.

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?
34422	Haemoperfusion system absorption column	A sterile container that is a component of a haemoperfusion system used for the removal of toxins from a patient's blood, and that holds materials (e.g., activated carbon or resins) which absorb (adsorb) a specific toxin or range of toxins. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FLD	Apparatus, hemoperfusion, sorbent

FDA Premarket Submission

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

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 4 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Weight: 150 Gram

Device Record Status

Public Device Record Key: 7c025cd7-2ec3-44bc-9032-64225f22657a
Public Version Date: February 05, 2024
Public Version Number: 7
DI Record Publish Date: September 24, 2016