Primary Device ID | 04719872650089 |
NIH Device Record Key | 2398b9f9-5f6a-4bb4-932a-74d48c51c9dc |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Guardian Angel™ Rx |
Version Model Number | GA-RS0004 |
Company DUNS | 116820893 |
Company Name | AULISA MEDICAL USA, INC. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | MR Unsafe |
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 | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 04719872650089 [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 | 2019-04-22 |
Device Publish Date | 2019-04-13 |
04719872650010 | Digital Vital Sign Monitoring System (with Adult / Pediatric Oximeter Sensor Cable) |
04719872650089 | Pediatric Oximeter Sensor Cable |
04719872650072 | Adult Oximeter Sensor Cable |
14719872650062 | Digital Vital Sign Monitoring System (with two Pediatric Oximeter Sensor Cables), RX ONLY |
14719872650055 | Digital Vital Sign Monitoring System (with two Adult Oximeter Sensor Cables), RX ONLY |
14719872650109 | Digital Vital Sign Monitoring System (with two Pediatric Oximeter Sensor Cables), RX ONLY |
14719872650093 | Digital Vital Sign Monitoring System (with two Adult Oximeter Sensor Cables), RX ONLY |
14719872650284 | Digital Vital Sign Monitoring System (with Infant Oximeter Module), RX ONLY |
14719872650031 | Digital Vital Sign Monitoring System (with Infant Oximeter Module), RX ONLY |