Identity
- Trade Name
- AMSure® Closed Suction System for Adults FDA UDI
- Generic Name
- Airway suction catheter FDA UDI
- Device Name
- Double Swivel Elbow, 24 hours, Tracheostomy, 10Fr 1 Closed Suction Catheter 1 15mm x 22mm Flex Adaptor 1 Day Sticker FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- Double Swivel Elbow, 24 hours, Tracheostomy, 10Fr 1 Closed Suction Catheter 1 15mm x 22mm Flex Adaptor 1 Day Sticker FDA UDI
Identifiers
- Catalog Number
- VS363TC124 FDA UDI
- Primary DI / UDI-DI
- 10704411012825 FDA UDI
- FDA Product Code
- BSY FDA UDI
- GMDN Term
- Airway suction catheter 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: Airway suction catheter
AMSure® Closed Suction System for Adults by Amsino International, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Airway suction catheter.
- AirLife™ — Airlife, Inc. · Class I
- Closed Suction Catheters — Ningbo Xinwell Medical Technology Co., Ltd. · Class I
- Closed Suction Catheters — Ningbo Xinwell Medical Technology Co., Ltd. · Class I
- Novo Surgical Inc. — NOVO SURGICAL, INC. · Class I
- Novo Surgical Inc. — NOVO SURGICAL, INC. · Class I
- Little Sucker Standard TP — Neotech Products LLC · Class II
- Closed Suction Catheters — Ningbo Xinwell Medical Technology Co., Ltd. · Class I
- Novo Surgical Inc. — NOVO SURGICAL, INC. · 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 |
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Manufacturer
- Manufacturer
- Amsino International, Inc.
Sources (1)
- FDA UDI c05e0b50-6c1e-441e-84b5-7808968763f1 34 fields · synced May 30, 2026