Primary Device ID | 00867661000349 |
NIH Device Record Key | c9872588-6186-47b1-80c2-ab92a1c37b5f |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Wireless Pulse Oximeter |
Version Model Number | WPO-10 |
Company DUNS | 079659378 |
Company Name | CLOUD DX 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 | true |
OTC Over-The-Counter | false |
Phone | 888-543-0944 |
regulatory@CloudDX.com | |
Phone | 888-543-0944 |
regulatory@CloudDX.com | |
Phone | 888-543-0944 |
regulatory@CloudDX.com | |
Phone | 888-543-0944 |
regulatory@CloudDX.com | |
Phone | 888-543-0944 |
regulatory@CloudDX.com | |
Phone | 888-543-0944 |
regulatory@CloudDX.com | |
Phone | 888-543-0944 |
regulatory@CloudDX.com | |
Phone | 888-543-0944 |
regulatory@CloudDX.com | |
Phone | 888-543-0944 |
regulatory@CloudDX.com | |
Phone | 888-543-0944 |
regulatory@CloudDX.com | |
Phone | 888-543-0944 |
regulatory@CloudDX.com | |
Phone | 888-543-0944 |
regulatory@CloudDX.com | |
Phone | 888-543-0944 |
regulatory@CloudDX.com | |
Phone | 888-543-0944 |
regulatory@CloudDX.com | |
Phone | 888-543-0944 |
regulatory@CloudDX.com | |
Phone | 888-543-0944 |
regulatory@CloudDX.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00867661000349 [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 | 2019-09-26 |
Device Publish Date | 2019-09-18 |
00867661000349 | WPO-10 |
00867661000356 | WPO-10B |