FDA UDI In Commercial Distribution 🇺🇸 United States

Merit Medical®

DI: 00884450038284 · Model: Initial Release · Merit Medical Systems, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
Merit Medical®
Primary DI
00884450038284
Version / Model
Initial Release
Catalog Number
K12-06044A
Company Name
Merit Medical Systems, Inc.
Labeler DUNS
184763290
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2025-09-18
Public Version
1
Public Version Date
2025-09-26
Public Version Status
New
Public Device Record Key
6db57648-3340-4d7b-b3c0-26280d7f8116

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
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
No
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
33961 General surgical procedure kit, non-medicated, single-use

Identifiers

Type ID
Package 10884450038281
Primary 00884450038284