AccessGUDID - DEVICE: AMSure® Urine Meter Drainage Bag (10704411013075)

GUDID

Device Identifier (DI) Information

Brand Name: AMSure® Urine Meter Drainage Bag
Version or Model: 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AS328
Company Name: AMSINO INTERNATIONAL, INC.

Primary DI Number: 10704411013075
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 825673239 *Terms of Use

Device Description: AMSure® Urine Meter Drainage Bag Contents: 400 cc Urine Meter with 2600 ml Drainage Bag Caution: Avoid freezing and excessive heat.

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:	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?
32072	Urine flowmeter, single-use	A non-electrical device that is used to measure the volume or flow of urine from a patient, either during the course of normal urination or while the patient is catheterized. The device may include a drip chamber to reduce the risk of retrograde bacterial contamination of the bladder. This device is a single-use device. This GMDN code may reflect old technology.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FFG	Device, Urine Flow Rate Measuring, Non-Electrical, Disposable

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
No Device Sizes

Device Record Status

Public Device Record Key: 6b3588f3-0da0-4e04-a229-5ea91caf9964
Public Version Date: October 26, 2020
Public Version Number: 1
DI Record Publish Date: October 16, 2020