FDA UDI
In Commercial Distribution
🇺🇸 United States
CAIRE Diagnostics
DI: 00860008017918
·
Model: Fenom Pro, US
·
Caire Diagnostics Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- CAIRE Diagnostics
- Primary DI
- 00860008017918
- Version / Model
- Fenom Pro, US
- Catalog Number
- 900-0005
- Company Name
- Caire Diagnostics Inc.
- Labeler DUNS
- 117548764
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-01-31
- Public Version
- 2
- Public Version Date
- 2022-03-08
- Public Version Status
- Update
- Public Device Record Key
- d650c8f8-13b4-490f-872e-8a32767b68b9
Device Description
Package contains: Fenom Pro Device - P/N 900-0001, GTIN 00860008017901 Configured for US Instructions for Use, Fenom Pro, US Configuration - P/N IFU-3393 AC Power Cord Cable, US - PN 415-0003
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
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| MXA | System, Test, Breath Nitric Oxide | Clinical Toxicology | 862.3080 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 13680 | Diagnostic spirometer, professional | An electrically-powered device designed exclusively for professional use to measure several or all respiratory gas volume and flow parameters for evaluation of basic pulmonary function [e.g., vital capacity (VC), peak expiratory flow (PEF), forced expiratory volume (FEV), and forced expiratory flow (FEF)]; it may also perform pulse oximetry. It is typically a hand-held instrument with a mouthpiece which communicates with a computerized unit (e.g., analysis system, graph recorder, tablet). It is used to help diagnosis and monitoring of chronic pulmonary disorders such as asthma, emphysema, or bronchitis, and potentially heart disorders. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860008017918 | GS1 |
Customer Contacts
- Phone
- 1 888 609-4839
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K182874 | 000 |