Identity
- Trade Name
- AMSure® Tracheostomy Care Tray EUDAMEDFDA UDI
- Generic Name
- Tracheostomy care kit, single-use FDA UDI
- Device Name
- Tracheostomy Care Tray EUDAMEDAMSure® Tracheostomy Care Tray FDA UDI
- Model / Reference
- AS860 EUDAMED1 FDA UDI
- Description
- AMSure® Tracheostomy Care Tray FDA UDI
Identifiers
- Catalog Number
- AS861 FDA UDIAS860 FDA UDI
- Primary DI / UDI-DI
- 10704411006398 EUDAMEDFDA UDI10704411006404 FDA UDI
- Basic UDI-DI
- B-10704411006398 EUDAMED
- FDA Product Code
- LRO FDA UDI
- EMDN Code
- M040203 TRACHEOSTOMY DRESSINGS EUDAMED
- GMDN Term
- Tracheostomy care kit, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4370 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Tracheostomy care kit, single-use
AMSure® Tracheostomy Care Tray by Amsino International, Inc. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Tracheostomy care kit, single-use.
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class II
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class II
- Busse Hospital Disposables — ROBERT BUSSE & CO., INC. · Class II
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class II
- AirLife™ — Airlife, Inc. · Class I
- Resp-O2 Tracheostomy Care Kit, 3-Compartment Tray w/ Vinyl Gloves — Dynarex Corp. · Class I
- Busse Hospital Disposables — ROBERT BUSSE & CO., INC. · Class II
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Amsino International, Inc.
Sources (3)
- FDA UDI adcc168c-3c07-4228-b6f0-b06315d416f3 34 fields · synced Jul 12, 2026
- FDA UDI 74ab99cb-1d0c-41b0-830c-dca56b9a3781 34 fields · synced May 30, 2026
- EUDAMED fda382ec-3688-4528-8845-b1caee87ba6c 61 fields · synced Jul 12, 2026