Identity
- Trade Name
- Analyzer FDA UDI
- Generic Name
- Respiratory oxygen monitor, line-powered FDA UDI
- Device Name
- Analyzer, MaxO2+A with Low Flow 15 LPM BlenderBuddy2 FDA UDI
- Model / Reference
- MaxO2+ FDA UDI
- Description
- Analyzer, MaxO2+A with Low Flow 15 LPM BlenderBuddy2 FDA UDI
Identifiers
- Catalog Number
- R233P04-005 FDA UDI
- Primary DI / UDI-DI
- 00817770025931 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
- 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Respiratory oxygen monitor, line-powered
Analyzer by Maxtec, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Respiratory oxygen monitor, line-powered.
- MySign® O — Honeywell Healthcare Solutions GmbH · Class II
- MAX02+AE OHIO ANALYZER — Maxtec, Inc. · Class II
- Analyzer — Maxtec, Inc. · Class II
- HANDI+, OHIO MEDICAL — Maxtec, Inc. · Class II
- MAXO2+ — Maxtec, Inc. · Class II
- MAXO2 ME — Maxtec, Inc. · Class II
- MaxO2+ AE — Maxtec, Inc. · Class II
- Analyzer — Maxtec, Inc. · Class II
Cleared under the same submission
K040484 also covers:
- 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.
- MAXO2+A OHIO ANALYZER — 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 48ec4702-1e14-4e4f-970e-5c3321ea1a9b 35 fields · synced Jun 8, 2026