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| 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 |
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