AccessGUDID - DEVICE: Gen2 (00840343705947)

GUDID

Device Identifier (DI) Information

Brand Name: Gen2
Version or Model: G2N28435
Commercial Distribution Status: In Commercial Distribution
Catalog Number: G2N28435
Company Name: SURGIX MEDICAL LLC

Primary DI Number: 00840343705947
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080402644 *Terms of Use
Previous DI: G277G2N284350

Device Description: CHROMA STYLE SUCTION TUBE WL 5-1/2" OAL 7-1/2" 8FR BLACK

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):	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?
34923	Suction system catheter, general-purpose	A sterile flexible tube used in the removal of fluids from the body via a natural body orifice, surgical incision, or wound. It is typically designed to be attached to a collection canister or bottle where a vacuum is created by a suction system via an intermediate tubing. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JOL	Catheter And Tip, Suction

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
Length: 7.5 Inch
Catheter Working Length: 5.5 Inch
Catheter Gauge: 8 French

Device Record Status

Public Device Record Key: c006c47d-eacd-46f1-b9d1-037688727197
Public Version Date: October 27, 2022
Public Version Number: 1
DI Record Publish Date: October 19, 2022