AccessGUDID - DEVICE: CarboJet® CO2 Bone Lavage System (00898142001500)

GUDID

Device Identifier (DI) Information

Brand Name: CarboJet® CO2 Bone Lavage System
Version or Model: 25-200-0242
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 25-200-0242
Company Name: Kinamed, Inc.

Primary DI Number: 00898142001500
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 184896645 *Terms of Use

Device Description: Femoral Suction Tube

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:	No
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?
64139	Bone cleaning gas-jet Y-piece connector	A Y-shaped tube intended to interface a bone cleaning gas-jet assembly and suction pump to allow gas [usually carbon dioxide (CO2)] and alternatively suction to be delivered to the surgical site during gas jet cleaning of bone during an open surgical orthopaedic procedure. This is a reusable device intended to be sterilized prior to use.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FQH	LAVAGE, JET

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: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

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: 0b8e6333-2182-47a2-acaf-0e2287ccc65c
Public Version Date: July 20, 2023
Public Version Number: 3
DI Record Publish Date: May 18, 2016