FDA UDI In Commercial Distribution 🇺🇸 United States

TempTraq

DI: 00851203006012 · Model: TT-100 · BLUE SPARK TECHNOLOGIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
TempTraq
Primary DI
00851203006012
Version / Model
TT-100
Catalog Number
601
Company Name
BLUE SPARK TECHNOLOGIES, INC.
Labeler DUNS
603031365
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-08-26
Public Version
4
Public Version Date
2021-02-25
Public Version Status
Update
Public Device Record Key
cb69d621-4c55-46a9-a5b8-04fd956b0c5e

Device Description

Continuous Temperature Monitor

Device Characteristics

Single Use
Yes
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
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
FLL Thermometer, Electronic, Clinical

GMDN Terms

Code Name
62170 Wireless patient thermometer, single-use

Identifiers

Type ID
Primary 00851203006012

Customer Contacts

Phone
14402495440

Storage Conditions

Type
Storage Environment Humidity
Temperature Range
15 – 95 Percent (%) Relative Humidity
Type
Storage Environment Temperature
Temperature Range
-4 – 122 Degrees Fahrenheit