FDA UDI In Commercial Distribution 🇺🇸 United States

TeleRPM & Chronica

DI: 00850042929223 · Model: I · Mio Labs Inc.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
TeleRPM & Chronica
Primary DI
00850042929223
Version / Model
I
Company Name
Mio Labs Inc.
Labeler DUNS
117119317
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2023-09-01
Public Version
2
Public Version Date
2023-11-13
Public Version Status
Update
Public Device Record Key
b77b7c73-8789-4d41-9d3a-b39dd1562ff3

Device Description

Single Use Lancets

Device Characteristics

Single Use
Yes
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
Yes
Has Manufacturing Date
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
QRL Multiple Use Blood Lancet For Single Patient Use Only
QRK Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature

GMDN Terms

Code Name
61579 Blood lancet, single-use

Identifiers

Type ID
Primary 00850042929223