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AMSure® Closed Suction System for Adults
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref AS365TC24Ref AS363TC124Ref AS364TC172Ref AS365TP72Ref AS365TTP124Ref AS365RC72Ref AS364TTP24Ref AS365RC24Ref AS366TTP24Ref AS366TP24Ref AS363RC72Ref AS365TTP24Ref AS364TC24Ref AS363TC72Ref AS366TC24Ref AS364TP24Ref AS363TP24Ref AS363TTP24Ref AS361RC24Ref AS363RC24
Identity
- Trade Name
- AMSure® Closed Suction System EUDAMEDAMSureⓇ Closed Suction System EUDAMEDAMSure® Closed Suction System for Adults FDA UDI
- Generic Name
- Airway suction catheter FDA UDI
- Device Name
- Closed Suction System EUDAMEDT-Piece, 24 hours, Tracheostomy, 14Fr 1 Closed Suction Catheter 1 MDI Adapter 1 22mm Flex Adapter 1 15mm x 22mm Adapter 1 15mm Straight Swivel Adapter 1 Day Sticker FDA UDI
- Model / Reference
- AS365TC24 EUDAMEDAS363TC124 EUDAMEDAS364TC172 EUDAMEDAS365TP72 EUDAMEDAS365TTP124 EUDAMEDAS365RC72 EUDAMEDAS364TTP24 EUDAMEDAS365RC24 EUDAMEDAS366TTP24 EUDAMEDAS366TP24 EUDAMEDAS363RC72 EUDAMEDAS365TTP24 EUDAMEDAS364TC24 EUDAMEDAS363TC72 EUDAMEDAS366TC24 EUDAMEDAS364TP24 EUDAMEDAS363TP24 EUDAMEDAS363TTP24 EUDAMEDAS361RC24 EUDAMEDAS363RC24 EUDAMED1 FDA UDI
- Description
- T-Piece, 24 hours, Tracheostomy, 14Fr 1 Closed Suction Catheter 1 MDI Adapter 1 22mm Flex Adapter 1 15mm x 22mm Adapter 1 15mm Straight Swivel Adapter 1 Day Sticker FDA UDI
Identifiers
- Catalog Number
- VS365TTP124 FDA UDI
- Primary DI / UDI-DI
- 10704411012337 EUDAMED10704411013990 EUDAMED10704411014058 EUDAMED10704411012566 EUDAMED10704411018018 EUDAMED10704411012474 EUDAMED10704411012412 EUDAMED10704411012290 EUDAMED10704411012436 EUDAMED10704411012382 EUDAMED10704411012450 EUDAMED10704411012429 EUDAMED10704411012320 EUDAMED10704411012498 EUDAMED10704411012344 EUDAMED10704411012368 EUDAMED10704411012351 EUDAMED10704411012405 EUDAMED10704411012252 EUDAMED10704411012276 EUDAMED10704411012887 FDA UDI
- Basic UDI-DI
- B-10704411012337 EUDAMEDB-10704411013990 EUDAMEDB-10704411014058 EUDAMEDB-10704411012566 EUDAMEDB-10704411018018 EUDAMEDB-10704411012474 EUDAMEDB-10704411012412 EUDAMEDB-10704411012290 EUDAMEDB-10704411012436 EUDAMEDB-10704411012382 EUDAMEDB-10704411012450 EUDAMEDB-10704411012429 EUDAMEDB-10704411012320 EUDAMEDB-10704411012498 EUDAMEDB-10704411012344 EUDAMEDB-10704411012368 EUDAMEDB-10704411012351 EUDAMEDB-10704411012405 EUDAMEDB-10704411012252 EUDAMEDB-10704411012276 EUDAMED
- FDA Product Code
- BSY FDA UDI
- EMDN Code
- R010399 ENDOTRACHEAL TUBES - OTHER EUDAMED
- GMDN Term
- Airway suction catheter FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 868.6810 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
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 — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — 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 (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 I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Amsino International, Inc.
Sources (21)
- FDA UDI bee933d5-9cc7-4233-8192-67678959213a 34 fields · synced Jul 30, 2026
- EUDAMED 58d9624c-f31b-4caf-869b-175b2a93eeb4 61 fields · synced Jul 8, 2026
- EUDAMED 9eebb28a-9afe-4b13-a7f0-892be06590d6 61 fields · synced Jul 8, 2026
- EUDAMED ae1bf162-1a34-42bd-8042-f93e2f589669 61 fields · synced Jul 8, 2026
- EUDAMED 37a9ba48-65a1-497f-a9c1-56d432311fac 61 fields · synced Jul 8, 2026
- EUDAMED 17d1792b-15b6-458d-abdb-30e64ba1ed0a 61 fields · synced Jul 8, 2026
- EUDAMED 72d415b2-ee28-4be0-b843-8a5e23de529c 61 fields · synced Jul 9, 2026
- EUDAMED 90a6a210-18cc-43bf-bf8c-24d4021c29c0 61 fields · synced Jul 9, 2026
- EUDAMED 5056212b-b800-4475-85dd-01a254f15e17 61 fields · synced Jul 9, 2026
- EUDAMED 5d64512a-3a4e-4b54-9f24-512b354c0346 61 fields · synced Jul 10, 2026
- EUDAMED bcbf2159-f35a-4800-8956-786cc036608c 61 fields · synced Jul 10, 2026
- EUDAMED 8aa39042-305d-40ff-87d9-4b1be3bb10b0 61 fields · synced Jul 11, 2026
- EUDAMED 65fe463a-e4c5-4ece-9d0e-f12dfca76741 61 fields · synced Jul 15, 2026
- EUDAMED 25096730-2369-4be4-9fb8-3ba9c8b22b26 61 fields · synced Jul 15, 2026
- EUDAMED df557103-1d98-4f92-9869-8fc28ee30d67 61 fields · synced Jul 21, 2026
- EUDAMED 6325badb-a802-4304-ad14-5b7ede08a264 61 fields · synced Jul 22, 2026
- EUDAMED a729f596-2221-4575-bb56-5dfd5a53b22e 61 fields · synced Jul 22, 2026
- EUDAMED df09cb0d-f3d3-4e30-9c77-e56f60608dc6 61 fields · synced Jul 24, 2026
- EUDAMED a3271976-82ba-4708-a9c8-aade4887e169 61 fields · synced Jul 25, 2026
- EUDAMED 6b129a43-b672-4a83-a29e-dda661c4fd4d 61 fields · synced Jul 27, 2026
- EUDAMED ae7a5e32-7b49-407a-a0cd-4171fb3d375f 61 fields · synced Jul 30, 2026