Duns Number:025460908
Device Description: ALL-IN-ONE - DUKE REGIONAL HOSPITAL PG
Catalog Number
600410911
Brand Name
NAMIC
Version/Model Number
600410911
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
OEZ
Product Code Name
Cardiovascular procedure kit
Public Device Record Key
abc4f24e-a3ee-40ae-bed4-7ec6e52a0b6c
Public Version Date
December 01, 2021
Public Version Number
1
DI Record Publish Date
November 23, 2021
Package DI Number
20193489087854
Quantity per Package
8
Contains DI Package
10193489087857
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 | 38540 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 85094 |
| 3 | A medical device with high risk that requires premarket approval | 2 |
| U | Unclassified | 7 |