FDA UDI
In Commercial Distribution
🇺🇸 United States
Resp-O2 Peak Flow Meter Low Range 50-300 L/min
DI: 00840117319035
·
Model: 36110
·
Dynarex Corporation
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Resp-O2 Peak Flow Meter Low Range 50-300 L/min
- Primary DI
- 00840117319035
- Version / Model
- 36110
- Company Name
- Dynarex Corporation
- Labeler DUNS
- 008124539
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-04-22
- Public Version
- 3
- Public Version Date
- 2024-10-09
- Public Version Status
- Update
- Public Device Record Key
- c71c76ca-e930-4a00-8a2f-093035de228f
Device Description
Pediatric
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| BZH | Meter, Peak Flow, Spirometry | Anesthesiology | 868.1860 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64672 | Inspiratory peak flow meter | A hand-held instrument designed to measure the maximum rate of oral or nasal inspiratory gas flow [peak inspiratory flow (PIF) or peak inspiratory flow rate (PIFR)] into the lungs, to assess airway patency. It is in the form of a cylinder with a mouthpiece for inhalation and a calibrated analogue scale that shows the peak flow value; a nasal mask may be attached to the device for evaluating nasal airway patency. It is used during pulmonary function testing as an alternative to rhinomanometry to help diagnose respiratory disorders [e.g., allergic rhinitis, chronic obstructive pulmonary disease (COPD)], or to assess/train medication inhalation technique. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00840117318786 | GS1 | Case | 10 | In Commercial Distribution | |
| Primary | 00840117319035 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K172804 | 000 |