FDA UDI In Commercial Distribution 🇺🇸 United States

PAD 3020-HP

DI: 00811331018059 · Model: PAD 3020-HP · Tz Medical, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
PAD 3020-HP
Primary DI
00811331018059
Version / Model
PAD 3020-HP
Company Name
Tz Medical, Inc.
Labeler DUNS
793149709
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2023-09-20
Public Version
1
Public Version Date
2023-09-28
Public Version Status
New
Public Device Record Key
11b35fe6-2f9d-4edb-b962-285cd2432ace

Device Description

TEST- ADAPTER CODEMASTER

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
Over the Counter (OTC)
No
Kit
No
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
No
Has Serial Number
Yes
Has Lot/Batch Number
No
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
DRO Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)

GMDN Terms

Code Name
41062 External defibrillation electrode, adult, reusable

Identifiers

Type ID
Primary 00811331018059

Premarket Submissions

Submission Number Supplement Number
K983196 000