Duns Number:116820893
Device Description: Digital Vital Sign Monitoring System (with two Pediatric Oximeter Sensor Cables), RX ONLY Digital Vital Sign Monitoring System (with two Pediatric Oximeter Sensor Cables), RX ONLY
Catalog Number
-
Brand Name
Guardian Angel™ Rx
Version/Model Number
GA1000-P
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 17, 2019
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
DQA
Product Code Name
Oximeter
Public Device Record Key
8f2f062b-6bb4-4ea4-ad85-a51dac0bc331
Public Version Date
December 16, 2019
Public Version Number
3
DI Record Publish Date
April 13, 2019
Package DI Number
14719872650062
Quantity per Package
1
Contains DI Package
04719872650065
Package Discontinue Date
May 17, 2019
Package Status
Not in Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 10 |