Identity
- Trade Name
- 15 mm Adaptor FDA UDI
- Generic Name
- Straight/elbow breathing circuit connector, single-use FDA UDI
- Device Name
- Size 4 x 15 mm FDA UDI
- Model / Reference
- 310404 FDA UDI
- Description
- Size 4 x 15 mm FDA UDI
Identifiers
- Catalog Number
- 310404 FDA UDI
- Primary DI / UDI-DI
- EBES3104040 FDA UDI
- 510(k) Number
- K802916 FDA UDI
- FDA Product Code
- BTO FDA UDI
- GMDN Term
- Straight/elbow breathing circuit connector, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
MR Safe FDA UDI
Category: Straight/elbow breathing circuit connector, single-use
15 mm Adaptor by Boston Medical Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K802916 also covers:
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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
- Boston Medical Products, Inc.
Sources (1)
- FDA UDI 9ed1a450-8512-4a81-8631-ecc4f612c0fe 38 fields · synced Jun 9, 2026