Cephus Catheter

GUDID 10860000559147

Barium enema catheter

Primary Device ID	10860000559147
NIH Device Record Key	84c93345-42e4-479c-85b5-8f4063f22f6b
Commercial Distribution Status	In Commercial Distribution
Brand Name	Cephus Catheter
Version Model Number	0006560
Company DUNS	079172500
Company Name	Sealcath, LLC
Device Count	1
DM Exempt	false
Pre-market Exempt	true
MRI Safety Status	MR Safe
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	true
RX Perscription	true
OTC Over-The-Counter	false

Storage Environment Temperature	Between 60 Degrees Fahrenheit and 76 Degrees Fahrenheit
Storage Environment Temperature	Between 60 Degrees Fahrenheit and 76 Degrees Fahrenheit
Storage Environment Temperature	Between 60 Degrees Fahrenheit and 76 Degrees Fahrenheit
Storage Environment Temperature	Between 60 Degrees Fahrenheit and 76 Degrees Fahrenheit
Storage Environment Temperature	Between 60 Degrees Fahrenheit and 76 Degrees Fahrenheit
Storage Environment Temperature	Between 60 Degrees Fahrenheit and 76 Degrees Fahrenheit
Storage Environment Temperature	Between 60 Degrees Fahrenheit and 76 Degrees Fahrenheit
Storage Environment Temperature	Between 60 Degrees Fahrenheit and 76 Degrees Fahrenheit
Storage Environment Temperature	Between 60 Degrees Fahrenheit and 76 Degrees Fahrenheit
Storage Environment Temperature	Between 60 Degrees Fahrenheit and 76 Degrees Fahrenheit
Storage Environment Temperature	Between 60 Degrees Fahrenheit and 76 Degrees Fahrenheit
Storage Environment Temperature	Between 60 Degrees Fahrenheit and 76 Degrees Fahrenheit
Storage Environment Temperature	Between 60 Degrees Fahrenheit and 76 Degrees Fahrenheit
Storage Environment Temperature	Between 60 Degrees Fahrenheit and 76 Degrees Fahrenheit
Storage Environment Temperature	Between 60 Degrees Fahrenheit and 76 Degrees Fahrenheit
Storage Environment Temperature	Between 60 Degrees Fahrenheit and 76 Degrees Fahrenheit
Storage Environment Temperature	Between 60 Degrees Fahrenheit and 76 Degrees Fahrenheit

Device Issuing Agency	Device ID
GS1	00860000559140 [Primary]
GS1	10860000559147 [Package] Contains: 00860000559140 Package: Box [10 Units] In Commercial Distribution

Enema kit

Steralize Prior To Use	false
Device Is Sterile	false