FDA UDI Not in Commercial Distribution 🇺🇸 United States

Redi-Temp®

DI: B2395010HB1 · Model: 5010-H-B · TRADEMARK MEDICAL, L.L.C.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
100

Basic Information

Brand Name
Redi-Temp®
Primary DI
B2395010HB1
Version / Model
5010-H-B
Catalog Number
5010-H-B
Company Name
TRADEMARK MEDICAL, L.L.C.
Labeler DUNS
024113805
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
100
Record Status
Published
Publish Date
2016-09-23
Public Version
4
Public Version Date
2021-09-22
Public Version Status
Update
Public Device Record Key
db0aca50-4e5a-4d65-ab71-fb99f2bff302
Distribution End Date
2020-03-31

Device Description

Liquid crystal temperature monitor strip (oval), individually wrapped, dispenser box

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
Yes
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
KPD Strip, Temperature, Forehead, Liquid Crystal

GMDN Terms

Code Name
33618 Liquid-crystal patient thermometer, single-use

Identifiers

Type ID
Primary B2395010HB1
Unit of Use B2395010HB0