FDA UDI In Commercial Distribution 🇺🇸 United States

MIO / TeleRPM

DI: 00850042929025 · Model: VGC01 · Mio Labs Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
MIO / TeleRPM
Primary DI
00850042929025
Version / Model
VGC01
Catalog Number
TeleBGM Control Solution
Company Name
Mio Labs Inc.
Labeler DUNS
117119317
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2022-09-20
Public Version
3
Public Version Date
2023-10-30
Public Version Status
Update
Public Device Record Key
eca6eda7-31ab-4225-b08e-600b09de7a10

Device Description

Mio Control Solution

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
Over the Counter (OTC)
Yes
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
NBW System, Test, Blood Glucose, Over The Counter

GMDN Terms

Code Name
62645 Glucose analyser IVD, home-use

Identifiers

Type ID
Primary 00850042929025