FDA Registration Active 🇺🇸 United States

ADTEMP II 413 DIGITAL THERMOMETERS AND COVERS / ADC ADTEMP DIGITAL THERMOMETER SHEATHS

Reg #: 3015997711 · FEI: 3015997711 · Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1

Registration Details

Registration Name
KATMAI INTEGRATED SOLUTIONS
Registration Number
3015997711
FEI Number
3015997711
Status
Active
Expiry Year
2025
Initial Importer
No
Address
34 Kelley Way
City
Brilliant
State
OH
ZIP
43913
Country
US

Regulatory Submissions

510(k) Number
K940686

Owner / Operator

Firm Name
Katmai Health Services, LLC
Operator Number
10050389
Address
701 E. Tudor Rd., Suite 215
City
Anchorage
State
AK
Postal Code
99503
Country
US
Correspondent
Lisa Talkington

Products

Device Name Product Code
Continuous Measurement Thermometer FLL

Proprietary Names

ADTEMP II 413 DIGITAL THERMOMETERS AND COVERS / ADC ADTEMP DIGITAL THERMOMETER SHEATHS ADTEMP™ 419 HYPOTHERMIA THERMOMETERS / ADC ADTEMP DIGITAL HYPOTHERMIA THERMOMETER

Establishment Types

Repack or Relabel Medical Device