Flowguard™ 10684-002

GUDID 10821329500029

Vascular catheter introduction set, nonimplantable

Primary Device ID	10821329500029
NIH Device Record Key	9289c58a-b4c9-480a-97ae-6307f5d03457
Commercial Distribution Status	In Commercial Distribution
Brand Name	Flowguard™
Version Model Number	10684-002
Catalog Number	10684-002
Company DUNS	968623467
Company Name	Greatbatch Ltd
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

Handling Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius

Device Issuing Agency	Device ID
GS1	00082139500026 [Primary]
GS1	00821329500022 [Primary]
GS1	10821329500029 [Package] Contains: 00821329500022 Package: BOX [5 Units] In Commercial Distribution

DYB	Introducer, Catheter

Steralize Prior To Use	false
Device Is Sterile	true

Mark Image Registration \| Serial	Company Trademark Application Date
FLOWGUARD 97732393 not registered Live/Pending	Flexxpoint Gutter Cover LLC 2022-12-27
FLOWGUARD 97003465 not registered Live/Pending	Lubrizol Advanced Materials, Inc. 2021-08-31
FLOWGUARD 90232272 not registered Live/Pending	Hoover Pumping Systems Corporation 2020-10-02
FLOWGUARD 88282522 not registered Live/Pending	Hoover Pumping Systems Corporation 2019-01-30
FLOWGUARD 87755170 5540878 Live/Registered	Des-Case Corporation 2018-01-15
FLOWGUARD 87275127 not registered Dead/Abandoned	Des-Case Corporation 2016-12-20
FLOWGUARD 85567443 not registered Dead/Abandoned	3-Flow, Inc. 2012-03-12
FLOWGUARD 78781949 not registered Dead/Abandoned	QUAN EMERTEQ CORP. 2005-12-28
FLOWGUARD 78668880 not registered Dead/Abandoned	InnerSpace, Inc. 2005-07-12
FLOWGUARD 77030313 3330282 Dead/Cancelled	LUBRIZOL ADVANCED MATERIALS, INC. 2006-10-26
FLOWGUARD 76647259 3352896 Live/Registered	Des-Case Corporation 2005-09-22
FLOWGUARD 76561289 2991117 Dead/Cancelled	ECtel Ltd. 2003-11-24