CAIRE Diagnostics 900-0001
GUDID 00860008017901
Package contains: External Power Supply, P/N 197-0001 Instructions for Use Reference, Fenom Pro - P/N FRM-3301
Caire Diagnostics Inc.
Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional| Primary Device ID | 00860008017901 |
| NIH Device Record Key | c5df5c28-a667-4d86-8a68-0d722d532540 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CAIRE Diagnostics |
| Version Model Number | Fenom Pro |
| Catalog Number | 900-0001 |
| Company DUNS | 117548764 |
| Company Name | Caire Diagnostics Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860008017901 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K182874
FDA Product Code
| MXA | System, Test, Breath Nitric Oxide |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-02-08 |
| Device Publish Date | 2022-01-31 |
On-Brand Devices [CAIRE Diagnostics]
| 00860008017956 | Box of 50 Fenom Pro Mouthpieces, PN 810-0006 Sold in box of 50 only, individual mouthpieces are |
| 00860008017949 | Package contains: Fenom Pro Device - P/N 900-0001, GTIN 00860008017901 Configured for Australia/ |
| 00860008017932 | Package contains: Fenom Pro Device - P/N 900-0001, GTIN 00860008017901 Configured as a Demo Unit |
| 00860008017925 | Package contains: Fenom Pro Device - P/N 900-0001, GTIN 00860008017901 Configured for EU Instruc |
| 00860008017918 | Package contains: Fenom Pro Device - P/N 900-0001, GTIN 00860008017901 Configured for US Instruc |
| 00860008017901 | Package contains: External Power Supply, P/N 197-0001 Instructions for Use Reference, Fenom Pro |
Trademark Results [CAIRE Diagnostics]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CAIRE DIAGNOSTICS 90132307 not registered Live/Pending |
CAIRE INC. 2020-08-24 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.