BD SurePath 490507

GUDID 00382904905071

Papanicolaou smear kit

Primary Device ID	00382904905071
NIH Device Record Key	318ac82d-51ab-4b31-be05-8c93eecb01b8
Commercial Distribution Discontinuation	2015-08-26
Commercial Distribution Status	Not in Commercial Distribution
Brand Name	BD SurePath
Version Model Number	490507
Catalog Number	490507
Company DUNS	103318015
Company Name	TRIPATH IMAGING, INC.
Device Count	1
DM Exempt	true
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	false
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 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius

Device Issuing Agency	Device ID
GS1	00382904905071 [Primary]

MKQ	Processor, Cervical Cytology Slide, Automated

Steralize Prior To Use	false
Device Is Sterile	false

00382904912475	BD SurePath™ GYN Cytology Test Kit
00382904905415	SurePath® Slide Library Kit
00382904905408	SurePath® GYN Collection Kit contains 100 collection vials used to preserve, transport, and sto
00382904905071	SurePath® Preservative Fluid
30382904905225	SurePath® GYN Preservative Vial Kit
30382904905119	SurePath® PreCoat Slides