Duns Number:058614483
Device Description: Pulse Oximetry Interface Cable,Unterminated,Caution: For manufacturing, processing or repa Pulse Oximetry Interface Cable,Unterminated,Caution: For manufacturing, processing or repacking.
Catalog Number
MCU10-10
Brand Name
Nellcor
Version/Model Number
MCU10-10
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 28, 2019
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K012891,K012891,K012891
Product Code
DQA
Product Code Name
Oximeter
Public Device Record Key
7654135e-9051-437a-9924-fa0bdef1b32e
Public Version Date
December 06, 2019
Public Version Number
4
DI Record Publish Date
September 24, 2016
Package DI Number
10884522042789
Quantity per Package
100
Contains DI Package
20884522042786
Package Discontinue Date
August 28, 2019
Package Status
Not 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 |