Primary Device ID | 00850042929452 |
NIH Device Record Key | 85bf8415-c89d-49dc-a523-2a3885d313c5 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | TeleRPM |
Version Model Number | YM402 |
Company DUNS | 117119317 |
Company Name | Mio Labs 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 | false |
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 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00850042929452 [Primary] |
DQA | Oximeter |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-04-10 |
Device Publish Date | 2024-04-02 |
00850042929452 | YM402 |
00850042929445 | TRK01 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
TELERPM 97521185 not registered Live/Pending |
Guangdong Transtek Medical Electronics Co., Ltd. 2022-07-26 |