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AMSure® Suction Catheter Tray
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref AS394Ref AS391Ref AS392Ref AS396
Identity
- Trade Name
- AMSure® Suction Catheter Tray EUDAMEDFDA UDI
- Generic Name
- Secretion suction kit FDA UDI
- Device Name
- Suction catheter kit EUDAMEDAMSure® Suction Catheter Tray SIZE:10Fr. CONTENTS: 1 ea Catheter 1 pair of Vinyl Gloves 1 bottle Sterile 0.9% Saline Solution, 100mL FDA UDIAMSure® Suction Catheter Tray SIZE:6Fr. CONTENTS: 1 ea Catheter 1 pair of Vinyl Gloves 1 bottle Sterile 0.9% Saline Solution, 100mL FDA UDIAMSure® Suction Catheter Tray SIZE:16Fr. CONTENTS: 1 ea Catheter 1 pair of Vinyl Gloves 1 bottle Sterile 0.9% Saline Solution, 100mL FDA UDIAMSure® Suction Catheter Tray SIZE:12Fr. CONTENTS: 1 ea Catheter 1 pair of Vinyl Gloves 1 bottle Sterile 0.9% Saline Solution, 100mL FDA UDIAMSure® Suction Catheter Tray SIZE:8Fr. CONTENTS: 1 ea Catheter 1 pair of Vinyl Gloves 1 bottle Sterile 0.9% Saline Solution, 100mL FDA UDI
- Model / Reference
- AS394 EUDAMEDAS391 EUDAMEDAS392 EUDAMEDAS396 EUDAMED1 FDA UDI
- Description
- AMSure® Suction Catheter Tray SIZE:10Fr. CONTENTS: 1 ea Catheter 1 pair of Vinyl Gloves 1 bottle Sterile 0.9% Saline Solution, 100mL FDA UDIAMSure® Suction Catheter Tray SIZE:6Fr. CONTENTS: 1 ea Catheter 1 pair of Vinyl Gloves 1 bottle Sterile 0.9% Saline Solution, 100mL FDA UDIAMSure® Suction Catheter Tray SIZE:16Fr. CONTENTS: 1 ea Catheter 1 pair of Vinyl Gloves 1 bottle Sterile 0.9% Saline Solution, 100mL FDA UDIAMSure® Suction Catheter Tray SIZE:12Fr. CONTENTS: 1 ea Catheter 1 pair of Vinyl Gloves 1 bottle Sterile 0.9% Saline Solution, 100mL FDA UDIAMSure® Suction Catheter Tray SIZE:8Fr. CONTENTS: 1 ea Catheter 1 pair of Vinyl Gloves 1 bottle Sterile 0.9% Saline Solution, 100mL FDA UDI
Identifiers
- Catalog Number
- AS393 FDA UDIAS391 FDA UDIAS396 FDA UDIAS394 FDA UDIAS392 FDA UDI
- Primary DI / UDI-DI
- 10704411008682 EUDAMEDFDA UDI10704411008736 EUDAMEDFDA UDI10704411008712 EUDAMEDFDA UDI10704411008699 EUDAMEDFDA UDI10704411008705 FDA UDI
- Basic UDI-DI
- B-10704411008712 EUDAMEDB-10704411008682 EUDAMEDB-10704411008699 EUDAMEDB-10704411008736 EUDAMED
- FDA Product Code
- BSY FDA UDI
- EMDN Code
- R040101 ANTIBACTERIAL AND ANTIVIRAL RESPIRATORY FILTERS EUDAMED
- GMDN Term
- Secretion suction kit FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA 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: Secretion suction kit
AMSure® Suction Catheter Tray by Amsino International, Inc. — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Secretion suction kit.
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- EXMOOR — Exmoor Plastics , Ltd. · Class I
- Bioseal Inc. — BIOSEAL · 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 (9)
- FDA UDI 08cd47e3-a2d3-46eb-81e0-ba48e6f13249 34 fields · synced Jul 27, 2026
- FDA UDI cd450c91-a438-4e4c-84b9-e48ec6013007 34 fields · synced May 30, 2026
- FDA UDI 13b807d4-4a2e-43d1-80cc-43951552fa4e 34 fields · synced May 30, 2026
- FDA UDI e52753d6-8d37-4c85-8975-87f71391ba17 34 fields · synced May 30, 2026
- FDA UDI a4253b2f-9710-4c1c-a9ca-c07d90991b70 34 fields · synced May 30, 2026
- EUDAMED 680235e1-9f48-4467-a759-def90a4e190a 61 fields · synced Jul 11, 2026
- EUDAMED 323a2f5c-416a-41d5-8ab1-cef33fc1cade 61 fields · synced Jul 11, 2026
- EUDAMED 5f62dab8-e262-475d-9591-4ebc4cf18c3b 61 fields · synced Jul 18, 2026
- EUDAMED cc901685-dfbd-4376-80fb-5693e65a4eca 61 fields · synced Jul 27, 2026