← Back to catalogue
Digital Ultra Pkg, B, Sed. System, w Bag
FDA UDIClass II (US FDA UDI)
by Accutron
Identity
- Trade Name
- Digital Ultra Pkg, B, Sed. System, w Bag FDA UDI
- Generic Name
- Oxygen/air/nitrous oxide breathing gas mixer FDA UDI
- Model / Reference
- 56100-SSB FDA UDI
Identifiers
- Catalog Number
- 56100-SSB FDA UDI
- Primary DI / UDI-DI
- 00813830028393 FDA UDI
- 510(k) Number
- K052335 FDA UDI
- FDA Product Code
- BSZ FDA UDI
- GMDN Term
- Oxygen/air/nitrous oxide breathing gas mixer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5160 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Digital Ultra Pkg, B, Sed. System, w Bag by Accutron — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K052335 also covers:
- 56800 Chair Conversion Kit — ACCUTRON
- Automatic Manifold, Digi-Flo — ACCUTRON
- Digital 4 Cylinder Stand — ACCUTRON
- Digital Newport Flowmeter System — ACCUTRON
- Digital Newport Power Coupler — ACCUTRON
- Digital Ultra Flushmount Package G — ACCUTRON
- Digital Ultra Flushmount Package H — ACCUTRON
- Digital Ultra Flushmount Package H CHAIR — ACCUTRON
- Digital Ultra Flushmount Package I — ACCUTRON
- Digital Ultra Flushmount Pkg. G, NS — ACCUTRON
- Digital Ultra Flushmount Pkg. H NS-CHAIR — ACCUTRON
- Digital Ultra Flushmount Pkg. H, NS — ACCUTRON
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
- Accutron
Sources (1)
- FDA UDI 1c6578c1-9727-4f83-a5f7-4d1067f86e43 35 fields · synced May 31, 2026