Identity
- Trade Name
- JOHN BUNN FDA UDI
- Generic Name
- Pulse oximeter FDA UDI
- Device Name
- DigiOx Finger Pulse Oximeter FDA UDI
- Model / Reference
- JB02007 FDA UDI
- Description
- DigiOx Finger Pulse Oximeter FDA UDI
Identifiers
- Primary DI / UDI-DI
- M368JB020071 FDA UDI
- 510(k) Number
- K063641 FDA UDI
- FDA Product Code
- DQA FDA UDI
- GMDN Term
- Pulse oximeter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2700 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
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Pulse oximeter
John Bunn by GF Health Products, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K063641 also covers:
- JOHN BUNN — GF Health Products, Inc
- MTS — MEDICAL TEST SUPPLY
- MTS — MEDICAL TEST SUPPLY
- MTS — MEDICAL TEST SUPPLY
- MTS — MEDICAL TEST SUPPLY
- MTS — MEDICAL TEST SUPPLY
- MTS — MEDICAL TEST SUPPLY
- BV Medical — Medical, Inc.
- BV Medical — Medical, Inc.
- BV Medical — Medical, Inc.
- Pulse Oximeter — Shenzhen Creative Industry Co., Ltd.
- Pulse Oximeter — Shenzhen Creative Industry Co., Ltd.
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
- GF Health Products, Inc
Sources (1)
- FDA UDI 60ce5c2a-a900-4a35-b31c-f171f5f2f50f 36 fields · synced May 30, 2026