Duns Number:145581588
Device Description: HOOK UP KIT WITH SINGLE USE POUCH, CASE OF 20
Catalog Number
50-0191
Brand Name
SPACELABS HEALTHCARE
Version/Model Number
TAY
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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"
Yes
For Single-Use
Yes
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
DSH
Product Code Name
RECORDER, MAGNETIC TAPE, MEDICAL
Public Device Record Key
2d8a6aa1-f609-4856-9ebc-2468ddb549f5
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
February 15, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 18 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 732 |