AccessGUDID - DEVICE: AMSure® Foley Catheter Tray (10704411019763)

GUDID

Device Identifier (DI) Information

Brand Name: AMSure® Foley Catheter Tray
Version or Model: 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AS882
Company Name: AMSINO INTERNATIONAL, INC.

Primary DI Number: 10704411019763
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 825673239 *Terms of Use

Device Description: "•FlexGRIP for Foley 11-18 Fr (sterilized using irradiation) (Poland) •1000mL Outer Basin Tray (sterilized using ethylene oxide) (China) •Benzalkonium Chloride Prep Pad (non-sterile) (USA) •10 mL Pre-filled Syringe with Sterile Water (sterilized using ethylene oxide) (China) •Vinyl Gloves (sterilized using ethylene oxide) (China) •Waterproof Drape (sterilized using ethylene oxide) (China) •Fenestrated Drape (sterilized using ethylene oxide) (China) •Lubricating Jelly (sterilized using ethylene oxide) (USA) •PVP Swabsticks (sterilized using ethylene oxide) (China)"

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?
61355	Urethral catheterization support kit, urinary drainage	A collection of non-surgically invasive devices intended to assist a healthcare professional to insert a urethral catheter (not included) into the urinary bladder, typically for drainage of urine; some types may also be intended for catheter removal. It typically includes forceps, dressings, gloves, and drapes; it does not include pharmaceuticals. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FCM	Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No 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: 8837fd93-9abe-4ad0-a39e-ef9605112bee
Public Version Date: July 09, 2025
Public Version Number: 1
DI Record Publish Date: July 01, 2025