AccessGUDID - DEVICE: Rospital Productos Medicos (00812460028377)

GUDID

Device Identifier (DI) Information

Brand Name: Rospital Productos Medicos
Version or Model: AMPSLB04
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AMPSLB04
Company Name: ATLAS MEDICAL PRODUCTS LLC

Primary DI Number: 00812460028377
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 013112308 *Terms of Use

Device Description: URINE BAG, 2000ML, ANTI-REFLUX VALVE, EA.

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:	Yes
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?
47459	Urine monitoring system collector	A sterile receptacle (e.g., a bag) designed to collect a patient's urine as part of a urine monitoring system. It is connected with tubing to the patient's indwelling catheter and is in contact with the system's urine output sensor. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KNX	Collector, Urine, (And Accessories) For Indwelling Catheter

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: Yes
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
Device Size Text, specify: URINE BAG, 2000ML, ANTI-REFLUX VALVE, EA.

Device Record Status

Public Device Record Key: ae2266bf-db8e-4191-87c9-3f09fedad871
Public Version Date: October 07, 2020
Public Version Number: 1
DI Record Publish Date: September 29, 2020