Adsorba Hemoperfusion cartridge

Basic Information

• Brand Name: Adsorba Hemoperfusion cartridge
• Primary DI: 07332414015473
• Version / Model: 300C
• Catalog Number: 101223
• Company Name: Gambro Dialysatoren GmbH
• Labeler DUNS: 316150549
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 6
• Public Version Date: 2024-02-05
• Public Version Status: Update
• Public Device Record Key: cb6f6eae-a874-4115-bb4d-9b99f29e8a83
• Distribution End Date: 2022-05-11

Device Description

The Adsorba 300C hemoperfusion cartridge is a steam sterilized device which contains 300 grams of cellulose-coated activated charcoal. The device is filled with physiological saline solution prior to sterilization.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FLD	Apparatus, hemoperfusion, sorbent	Gastroenterology, Urology	876.5870	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	37332414015474	GS1	BOX	6	Not in Commercial Distribution	2022-05-11
Primary	07332414015473	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Weight	300	Gram

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 4 – 30 Degrees Celsius