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Resp-O2 Peak Flow Meter Low Range 50-300 L/min
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Resp-O2 Peak Flow Meter Low Range 50-300 L/min FDA UDI
- Generic Name
- Inspiratory peak flow meter FDA UDI
- Device Name
- Pediatric FDA UDI
- Model / Reference
- 36110 FDA UDI
- Description
- Pediatric FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840117319035 FDA UDI
- 510(k) Number
- K172804 FDA UDI
- FDA Product Code
- BZH FDA UDI
- GMDN Term
- Inspiratory peak flow meter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.1860 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Inspiratory peak flow meter
Resp-O2 Peak Flow Meter Low Range 50-300 L/min by Dynarex Corp. — Class II — MDR, MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Inspiratory peak flow meter.
- Medline — MEDLINE INDUSTRIES, INC. · Class II
- Walgreens — WALGREEN CO. · Class II
- Resp-O2 Peak Flow Meter Full Range 50-800 L/min — Dynarex Corp. · Class II
Cleared under the same submission
K172804 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Dynarex Corp.
Sources (2)
- FDA UDI c71c76ca-e930-4a00-8a2f-093035de228f 34 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 4, 2026