FDA UDI In Commercial Distribution 🇺🇸 United States

Hose, Set of 6 (Models MC2, TS3, TS4)

DI: 00817980021259 · Model: Model TS-4 · VASOMEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Hose, Set of 6 (Models MC2, TS3, TS4)
Primary DI
00817980021259
Version / Model
Model TS-4
Catalog Number
V23-0078-0
Company Name
VASOMEDICAL, INC.
Labeler DUNS
197210248
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-11-29
Public Version
3
Public Version Date
2018-07-06
Public Version Status
Update
Public Device Record Key
eb019e95-9ee9-4ff5-ab02-c356702db2c2

Device Description

Hose, Set of 6 (Models MC2, TS3, TS4)

Device Characteristics

Single Use
No
Prescription Use (Rx)
Yes
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
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
DRN Device, counter-pulsating, external

GMDN Terms

Code Name
61282 External counterpulsation system, stationary

Identifiers

Type ID
Primary 00817980021259

Customer Contacts

Premarket Submissions

Submission Number Supplement Number
K033617 000