AccessGUDID - DEVICE: CHEMETRON (00260720002436)

GUDID

Device Identifier (DI) Information

Brand Name: CHEMETRON
Version or Model: 20-02-0028
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 20-02-0028
Company Name: ALLIED HEALTHCARE PRODUCTS, INC.

Primary DI Number: 00260720002436
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 099674145 *Terms of Use

Device Description: SLIDE BRACKET KIT SET OF 4

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 Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Suction system bottle/canister sealing set	A sterile collection of items intended to be inserted into a suction system bottle/canister to facilitate air tightness of the container and maintain the vacuum. It typically includes synthetic polymer sealing rings and a plug. This is a single-use device.

FDA Product Code

[?]

Product Code	Product Code Name
KDQ	Bottle, Collection, Vacuum

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: d981c026-9bf9-4357-9b84-a0a90cef89f2
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: August 17, 2016