Duns Number:058614483
Device Description: Preamplifier. For use with PM7100
Catalog Number
-
Brand Name
INVOS
Version/Model Number
PMPAMP71
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
K182868,K211561,K182868,K211561
Product Code
MUD
Product Code Name
Oximeter, tissue saturation
Public Device Record Key
c035f0f2-d9ca-420d-9d41-7f11d15b9bcb
Public Version Date
September 22, 2022
Public Version Number
10
DI Record Publish Date
June 12, 2019
Package DI Number
10884521712805
Quantity per Package
12
Contains DI Package
10884521552616
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 132 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8540 |
| 3 | A medical device with high risk that requires premarket approval | 202 |
| U | Unclassified | 40 |