Primary Device ID | 00850000967304 |
NIH Device Record Key | 2f1f5f6c-2f69-4bec-888c-0d37d6699086 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | OxyKnight |
Version Model Number | CF-100 |
Company DUNS | 079963616 |
Company Name | CMI HEALTH INC. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
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 | true |
Serial Number | false |
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 | true |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00850000967304 [Primary] |
OCH | Oximeter, Infrared, Sporting, Aviation |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-07-11 |
Device Publish Date | 2024-07-03 |
00850000967410 | OxyKnight Fingertip Oximeter CF-100A |
00850000967403 | OxyKnight Fingertip Oximeter CF-100B |
00850000967304 | OxyKnight Fingertip Oximeter CF-100 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
OXYKNIGHT 88089790 5904715 Live/Registered |
Telomed, LLC 2018-08-23 |