FDA UDI In Commercial Distribution 🇺🇸 United States

EndoAVF® Balloon Inflation Kit

DI: 00884450413838 · Model: 00884450413838 · Merit Medical Systems, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1

Basic Information

Brand Name
EndoAVF® Balloon Inflation Kit
Primary DI
00884450413838
Version / Model
00884450413838
Catalog Number
K05-03125
Company Name
Merit Medical Systems, Inc.
Labeler DUNS
184763290
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2019-09-18
Public Version
3
Public Version Date
2021-04-28
Public Version Status
Update
Public Device Record Key
5163045f-b812-4fb7-8a0f-cba426a7f3a9

Device Characteristics

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

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
OEQ Angiography/angioplasty kit

GMDN Terms

Code Name
17541 Catheter/overtube balloon inflator, single-use

Identifiers

Type ID
Package 10884450413835
Primary 00884450413838
Package 20884450413832