AccessGUDID - DEVICE: Intussusception Air Reduction Bulb & Gauge with Plastic Case (00860002476148)

GUDID

Device Identifier (DI) Information

Brand Name: Intussusception Air Reduction Bulb & Gauge with Plastic Case
Version or Model: IARB-KIT
Commercial Distribution Status: In Commercial Distribution
Catalog Number: IARB-KIT
Company Name: GRI MEDICAL PRODUCTS INC

Primary DI Number: 00860002476148
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 005875146 *Terms of Use

Device Description: Intussusception Air Reduction Bulb & Gauge with Plastic Case

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:	Yes
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?
35050	Gravity enema set	A collection of devices intended to be used to deliver an injection of fluid (e.g., saline solution) into the rectum to facilitate evacuation of the large intestine. It includes a fluid reservoir (e.g., enema bag) which acts as a gravity-flow chamber, and typically includes enema tube(s) and enema tip; it may be prefilled with a non-medicated enema solution and may be available preassembled. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KQT	Evacuator, Gastro-Urology

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: 86328b05-6cb1-4615-8e8e-b773793f9b72
Public Version Date: December 26, 2019
Public Version Number: 1
DI Record Publish Date: December 18, 2019