FDA UDI In Commercial Distribution 🇺🇸 United States

Holter Monitor

DI: 00860002827308 · Model: Model 950-3CH · MEMTEC CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Holter Monitor
Primary DI
00860002827308
Version / Model
Model 950-3CH
Catalog Number
1
Company Name
MEMTEC CORPORATION
Labeler DUNS
001048925
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2019-11-15
Public Version
1
Public Version Date
2019-11-25
Public Version Status
New
Public Device Record Key
cb54d5d0-a772-4a13-9e03-411a7b0cb6ff
Distribution End Date
2029-11-15

Device Description

Holter Monitor

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
MR Unsafe
Direct Marking Exempt
Yes
PM Exempt
No
Has Serial Number
No
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
DSH Recorder, Magnetic Tape, Medical

GMDN Terms

Code Name
36827 Electrocardiographic long-term ambulatory recording analyser

Identifiers

Type ID
Primary 00860002827308