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AMSure® Coiled Suction Catheter
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref AS360CRef AS364CRef AS365CRef AS366C
Identity
- Trade Name
- AMSure® Coiled Suction Catheter EUDAMEDFDA UDI
- Generic Name
- Secretion suction kit FDA UDI
- Device Name
- Suction Catheter EUDAMEDAMSure® Coiled Suction Catheter SIZE:8Fr. FDA UDIAMSure® Coiled Suction Catheter SIZE:14Fr. FDA UDIAMSure® Coiled Suction Catheter SIZE:16Fr. FDA UDIAMSure® Coiled Suction Catheter SIZE:12Fr. FDA UDIAMSure® Coiled Suction Catheter SIZE:5Fr. FDA UDI
- Model / Reference
- AS360C EUDAMEDAS364C EUDAMEDAS365C EUDAMEDAS366C EUDAMED1 FDA UDI
- Description
- AMSure® Coiled Suction Catheter SIZE:8Fr. FDA UDIAMSure® Coiled Suction Catheter SIZE:14Fr. FDA UDIAMSure® Coiled Suction Catheter SIZE:16Fr. FDA UDIAMSure® Coiled Suction Catheter SIZE:12Fr. FDA UDIAMSure® Coiled Suction Catheter SIZE:5Fr. FDA UDI
Identifiers
- Catalog Number
- AS362C FDA UDIAS365C FDA UDIAS366C FDA UDIAS364C FDA UDIAS360C FDA UDI
- Primary DI / UDI-DI
- 10704411007951 EUDAMEDFDA UDI10704411007968 EUDAMEDFDA UDI10704411007944 EUDAMEDFDA UDI10704411010036 EUDAMEDFDA UDI10704411007920 FDA UDI
- Basic UDI-DI
- B-10704411010036 EUDAMEDB-10704411007944 EUDAMEDB-10704411007951 EUDAMEDB-10704411007968 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® Coiled Suction Catheter by Amsino International, Inc. — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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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 39972b39-41af-4628-940e-b65c762a525b 34 fields · synced Jul 30, 2026
- FDA UDI 4c6a3c9c-4ab3-46d5-9697-93501d31177b 34 fields · synced May 29, 2026
- FDA UDI 300df076-14e5-46c4-b368-bdf674eb9589 34 fields · synced May 29, 2026
- FDA UDI 5089cf39-8aca-4c72-b926-b28c2ba6a23e 34 fields · synced May 29, 2026
- FDA UDI b3a3a515-2cd8-4e3e-a9c5-79ba761fa2f6 34 fields · synced May 30, 2026
- EUDAMED 3f665378-d94d-41c0-b870-3528600f4e92 61 fields · synced Jul 14, 2026
- EUDAMED 5d01e8ad-7615-41d8-b0ec-083b244ba1e6 61 fields · synced Jul 17, 2026
- EUDAMED 52439128-04d3-4790-886a-0583aaa6e426 61 fields · synced Jul 21, 2026
- EUDAMED 61026b76-1865-48ec-b456-d43aae3110b8 61 fields · synced Jul 30, 2026