Identity
- Trade Name
- Inca FDA UDI
- Generic Name
- Nasal oxygen cannula, CPAP FDA UDI
- Device Name
- Replacement Set 10.5F FDA UDI
- Model / Reference
- 44-0710 FDA UDI
- Description
- Replacement Set 10.5F FDA UDI
Identifiers
- Primary DI / UDI-DI
- 60888937009509 FDA UDI
- 510(k) Number
- K911780 FDA UDI
- FDA Product Code
- BZD FDA UDI
- GMDN Term
- Nasal oxygen cannula, CPAP FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5905 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
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: Nasal oxygen cannula, CPAP
Inca by CooperSurgical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Nasal oxygen cannula, CPAP.
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- Inspire — Inspiration Healthcare, Ltd. · Class I
- Argyle — Cardinalhealth · Class II
- HUDSON RCI — TELEFLEX INCORPORATED · Class II
- Infant Flow™ — VYAIRE MEDICAL, INC. · Class II
- VYGON — Vygon Corp. · Class I
Cleared under the same submission
K911780 also covers:
- Inca — CooperSurgical, Inc.
- Inca — CooperSurgical, Inc.
- Inca — CooperSurgical, Inc.
- Inca — CooperSurgical, Inc.
- Inca — CooperSurgical, Inc.
- Inca — CooperSurgical, Inc.
- Inca — CooperSurgical, Inc.
- Inca — CooperSurgical, Inc.
- Inca — CooperSurgical, Inc.
- Inca — CooperSurgical, Inc.
- Inca — CooperSurgical, Inc.
- Inca — CooperSurgical, Inc.
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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- CooperSurgical, Inc.
Sources (1)
- FDA UDI 098b7eb3-7857-4d60-a212-5806759352f0 34 fields · synced Jun 9, 2026