Identity
- Trade Name
- AMSure® Coiled Suction Catheter FDA UDI
- Generic Name
- Secretion suction kit FDA UDI
- Device Name
- AMSure® Coiled Suction Catheter SIZE:6Fr. FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- AMSure® Coiled Suction Catheter SIZE:6Fr. FDA UDI
Identifiers
- Catalog Number
- AS361C FDA UDI
- Primary DI / UDI-DI
- 10704411007913 FDA UDI
- FDA Product Code
- BSY FDA UDI
- GMDN Term
- Secretion suction kit FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.6810 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Secretion suction kit
AMSure® Coiled Suction Catheter by Amsino International, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Secretion suction kit.
- EXMOOR — Exmoor Plastics , Ltd. · Class I
- Suction Catheter Kits, Disposable — Dynarex Corp. · Class I
- AirLife™ Mini-Filter/S, Disposable — AirLife Finland Oy · Class IIa
- HITECARE — Ningbo Boya Medical Equipment Co., Ltd · Class IIa
- RespVac™ — CUTTING EDGE HC BRANDS LLC · Class I
- Breathing Filter — Ningbo Luke Medical Devices Co.,LTD · Class IIa
- EXMOOR — Exmoor Plastics , Ltd. · Class I
- Bioseal Inc. — BIOSEAL · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Amsino International, Inc.
Sources (1)
- FDA UDI b8362420-5583-49e6-be23-1cf791db8f8e 34 fields · synced Jun 8, 2026