Identity
- Trade Name
- BIO MED FDA UDI
- Generic Name
- Respiratory oxygen monitor, line-powered FDA UDI
- Device Name
- Analyzer with BlenderBuddy International 0-15 with DISS FDA UDI
- Model / Reference
- R219P62-001 FDA UDI
- Description
- Analyzer with BlenderBuddy International 0-15 with DISS FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817770021018 FDA UDI
- 510(k) Number
- K040484 FDA UDI
- FDA Product Code
- CCL FDA UDI
- GMDN Term
- Respiratory oxygen monitor, line-powered FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.1720 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
No
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
No
FDA UDI
Bio Med by Maxtec, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K040484 also covers:
- Analyzer — Maxtec, Inc.
- Analyzer — Maxtec, Inc.
- Analyzer — Maxtec, Inc.
- BlenderBuddy2 — Maxtec, Inc.
- BlenderBuddy2 — Maxtec, Inc.
- BlenderBuddy2 — Maxtec, Inc.
- BlenderBuddy2 — Maxtec, Inc.
- MAX02+ — Maxtec, Inc.
- MAX02+AE OHIO ANALYZER — Maxtec, Inc.
- MAXO2+ — Maxtec, Inc.
- MAXO2+ — Maxtec, Inc.
- MAXO2+ — Maxtec, 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 |
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Manufacturer
- Manufacturer
- Maxtec, Inc.
Sources (1)
- FDA UDI 4c00a172-061e-496b-9c4f-8ca7840ae46b 35 fields · synced May 30, 2026