FDA UDI
In Commercial Distribution
🇺🇸 United States
AMSure® Foley Catheter Tray
DI: 10704411019770
·
Model: 1
·
AMSINO INTERNATIONAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- AMSure® Foley Catheter Tray
- Primary DI
- 10704411019770
- Version / Model
- 1
- Catalog Number
- AS892
- Company Name
- AMSINO INTERNATIONAL, INC.
- Labeler DUNS
- 825673239
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-07-01
- Public Version
- 1
- Public Version Date
- 2025-07-09
- Public Version Status
- New
- Public Device Record Key
- 7149a84a-3e1a-4448-9c3b-61170dfbb63b
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) •30 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
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FCM | Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) | Gastroenterology, Urology | 876.5130 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 40704411019771 | GS1 | Case | 20 | In Commercial Distribution | |
| Primary | 10704411019770 | GS1 |