8001 Series Foley Catheter Temperature Probe 8001-063-416

GUDID H29780010634160

General-purpose patient temperature probe, single-use

Primary Device ID	H29780010634160
NIH Device Record Key	a4cb6dbb-0d5e-43f2-a71f-3c8326beb5b6
Commercial Distribution Status	In Commercial Distribution
Brand Name	8001 Series Foley Catheter Temperature Probe
Version Model Number	8001-063-416
Catalog Number	8001-063-416
Company DUNS	029351079
Company Name	MEASUREMENT SPECIALTIES, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Storage Environment Temperature	Between -5 Degrees Celsius and 55 Degrees Celsius
Storage Environment Temperature	Between -5 Degrees Celsius and 55 Degrees Celsius
Storage Environment Temperature	Between -5 Degrees Celsius and 55 Degrees Celsius
Storage Environment Temperature	Between -5 Degrees Celsius and 55 Degrees Celsius
Storage Environment Temperature	Between -5 Degrees Celsius and 55 Degrees Celsius
Storage Environment Temperature	Between -5 Degrees Celsius and 55 Degrees Celsius
Storage Environment Temperature	Between -5 Degrees Celsius and 55 Degrees Celsius
Storage Environment Temperature	Between -5 Degrees Celsius and 55 Degrees Celsius
Storage Environment Temperature	Between -5 Degrees Celsius and 55 Degrees Celsius
Storage Environment Temperature	Between -5 Degrees Celsius and 55 Degrees Celsius
Storage Environment Temperature	Between -5 Degrees Celsius and 55 Degrees Celsius
Storage Environment Temperature	Between -5 Degrees Celsius and 55 Degrees Celsius
Storage Environment Temperature	Between -5 Degrees Celsius and 55 Degrees Celsius

Device Issuing Agency	Device ID
HIBCC	H29780010634160 [Primary]
HIBCC	H29780010634161 [Package] Package: Inner Box [10 Units] In Commercial Distribution
HIBCC	H29780010634162 [Package] Contains: H29780010634161 Package: Outer Box [10 Units] In Commercial Distribution

EZL	Catheter, Retention Type, Balloon

Steralize Prior To Use	false
Device Is Sterile	true

H29780010634160	8001 Series Foley Catheter Temperature Probe, 16 FR
H29780010634142	8001 Series Foley Catheter Temperature Probe, 14 FR