AccessGUDID - DEVICE: MEDI-VAC (00630140153108)

GUDID

Device Identifier (DI) Information

Brand Name: MEDI-VAC
Version or Model: 65652-135
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 65652-135
Company Name: Cardinal Health 200, LLC

Primary DI Number: 00630140153108
Issuing Agency: GS1
Commercial Distribution End Date: July 22, 2016
Device Count: 1
Labeler D-U-N-S® Number*: 961027315 *Terms of Use

Device Description: Ring Brkt W/Strt Conn - 2/3000cc

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":	Yes
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
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?
42446	Suction/irrigation system canister/bottle holder, single-use	A device intended to be used to hold a dedicated fluid or collection/specimen canister or bottle that is used within a suction and/or irrigation system. This device can be used to mount the canister/bottle(s) to the parent system when it is mobile (on wheels), or to mount the canister/bottle to a medical device service rail system or a wall rail (typically used on the ward). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GCX	APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED

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: No

Sterilization Method [?]
No Sterilization Methods Found

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: 6d9d0f96-53a8-4a42-be88-e2ca27d7ee65
Public Version Date: March 22, 2022
Public Version Number: 5
DI Record Publish Date: July 22, 2016