FDA UDI In Commercial Distribution 🇺🇸 United States

NAMIC

DI: H965606212610 · Model: 60621261 · NAVILYST MEDICAL, INC.
Product Codes
0
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
NAMIC
Primary DI
H965606212610
Version / Model
60621261
Company Name
NAVILYST MEDICAL, INC.
Labeler DUNS
809699023
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2018-09-05
Public Version
1
Public Version Date
2018-10-08
Public Version Status
New
Public Device Record Key
a2495dbe-ef14-485c-913d-262277b67b09

Device Description

NAMIC Convenience Kit

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
Yes
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
Yes
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
No
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

GMDN Terms

Code Name
16545 Angiography kit

Identifiers

Type ID
Package H965606212611
Primary H965606212610

Customer Contacts