FDA UDI
In Commercial Distribution
🇺🇸 United States
AMSure® Preconnected Urethral Tray
DI: 10704411017776
·
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® Preconnected Urethral Tray
- Primary DI
- 10704411017776
- Version / Model
- 1
- Catalog Number
- AS89214
- Company Name
- AMSINO INTERNATIONAL, INC.
- Labeler DUNS
- 825673239
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-06-24
- Public Version
- 1
- Public Version Date
- 2025-07-02
- Public Version Status
- New
- Public Device Record Key
- a123b63a-4d07-4c16-bc93-d174d14f49e0
Device Description
– 1200ml Drainage Bag with Pre-Connected 14 Fr Vinyl Urethral Catheter(China) – CSR Wrap(China)– Waterproof Absorbent Underpad(China) – Pre-Cuffed Nitrile Gloves (2)(China) – Fenestrated Drape(China) – Povidone-Iodine Swabsticks (3)(China) – Package Sterile Lubricating Jelly(USA) – 2oz Specimen Container with ID Label(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 |
|---|---|---|---|---|
| 47778 | Intermittent urethral catheterization kit | A collection of devices that includes a urological catheter (with or without a urine drainage bag), a cap, and other related accessories (e.g., gloves, drapes, tray) intended for self-urinary catheterization. The catheter may be repeatedly inserted through the urethra by the user to provide short-term, episodic urine drainage. It is typically pre-lubricated or coated with, made of, or includes materials/substances that facilitate easy insertion and removal [e.g., polytetrafluoroethylene (PTFT) commonly known as Teflon, or glass]; it might also be coated with or include antimicrobial materials/substances to help prevent infection of the urinary tract. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 40704411017777 | GS1 | Case | 20 | In Commercial Distribution | |
| Primary | 10704411017776 | GS1 |