FDA UDI In Commercial Distribution 🇺🇸 United States

Vista Solution® 10-day Evaluation Kit

DI: 00850490007269 · Model: 9410-01 · Vital Connect, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Vista Solution® 10-day Evaluation Kit
Primary DI
00850490007269
Version / Model
9410-01
Catalog Number
9410-01
Company Name
Vital Connect, Inc.
Labeler DUNS
944642730
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2020-11-04
Public Version
1
Public Version Date
2020-11-12
Public Version Status
New
Public Device Record Key
4cf77a47-c04c-4f1e-b30d-33fea96f6887

Device Description

Vista Solution® 10-day Evaluation Kit

Device Characteristics

Single Use
No
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
No
PM Exempt
No
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
DRG Transmitters And Receivers, Physiological Signal, Radiofrequency

GMDN Terms

Code Name
31733 Electrocardiography telemetric monitoring system

Identifiers

Type ID
Primary 00850490007269

Premarket Submissions

Submission Number Supplement Number
K192757 000
K193343 000