Flowguard™ 10684-003

GUDID 10821329400527

Valved Peelable Introducer

Greatbatch Ltd

Vascular catheter introduction set, nonimplantable

Primary Device ID	10821329400527
NIH Device Record Key	c48adb05-6db4-4302-90ef-e7c2f2785a1f
Commercial Distribution Status	In Commercial Distribution
Brand Name	Flowguard™
Version Model Number	10684-003
Catalog Number	10684-003
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

Device Dimensions

Length	13.2 Centimeter
Length	13.2 Centimeter
Length	13.2 Centimeter
Length	13.2 Centimeter
Length	13.2 Centimeter
Length	13.2 Centimeter
Length	13.2 Centimeter
Length	13.2 Centimeter
Length	13.2 Centimeter
Length	13.2 Centimeter
Outer Diameter	5.4 Millimeter
Lumen/Inner Diameter	0.9 Millimeter
Catheter Gauge	16 French
Lumen/Inner Diameter	5.2 Millimeter
Length	13.2 Centimeter
Outer Diameter	5.4 Millimeter
Lumen/Inner Diameter	0.9 Millimeter
Catheter Gauge	16 French
Lumen/Inner Diameter	5.2 Millimeter
Length	13.2 Centimeter
Outer Diameter	5.4 Millimeter
Lumen/Inner Diameter	0.9 Millimeter
Catheter Gauge	16 French
Lumen/Inner Diameter	5.2 Millimeter
Length	13.2 Centimeter
Outer Diameter	5.4 Millimeter
Lumen/Inner Diameter	0.9 Millimeter
Catheter Gauge	16 French
Lumen/Inner Diameter	5.2 Millimeter
Length	13.2 Centimeter
Outer Diameter	5.4 Millimeter
Lumen/Inner Diameter	0.9 Millimeter
Catheter Gauge	16 French
Lumen/Inner Diameter	5.2 Millimeter
Length	13.2 Centimeter
Outer Diameter	5.4 Millimeter
Lumen/Inner Diameter	0.9 Millimeter
Catheter Gauge	16 French
Lumen/Inner Diameter	5.2 Millimeter
Length	13.2 Centimeter
Outer Diameter	5.4 Millimeter
Lumen/Inner Diameter	0.9 Millimeter
Catheter Gauge	16 French
Lumen/Inner Diameter	5.2 Millimeter
Length	13.2 Centimeter
Outer Diameter	5.4 Millimeter
Lumen/Inner Diameter	0.9 Millimeter
Catheter Gauge	16 French
Lumen/Inner Diameter	5.2 Millimeter
Length	13.2 Centimeter
Outer Diameter	5.4 Millimeter
Lumen/Inner Diameter	0.9 Millimeter
Catheter Gauge	16 French
Lumen/Inner Diameter	5.2 Millimeter
Length	13.2 Centimeter
Outer Diameter	5.4 Millimeter
Lumen/Inner Diameter	0.9 Millimeter
Catheter Gauge	16 French
Lumen/Inner Diameter	5.2 Millimeter
Length	13.2 Centimeter
Outer Diameter	5.4 Millimeter
Lumen/Inner Diameter	0.9 Millimeter
Catheter Gauge	16 French
Lumen/Inner Diameter	5.2 Millimeter
Length	13.2 Centimeter
Outer Diameter	5.4 Millimeter
Lumen/Inner Diameter	0.9 Millimeter
Catheter Gauge	16 French
Lumen/Inner Diameter	5.2 Millimeter
Length	13.2 Centimeter
Outer Diameter	5.4 Millimeter
Lumen/Inner Diameter	0.9 Millimeter
Catheter Gauge	16 French
Lumen/Inner Diameter	5.2 Millimeter
Length	13.2 Centimeter
Outer Diameter	5.4 Millimeter
Lumen/Inner Diameter	0.9 Millimeter
Catheter Gauge	16 French
Lumen/Inner Diameter	5.2 Millimeter
Length	13.2 Centimeter
Outer Diameter	5.4 Millimeter
Lumen/Inner Diameter	0.9 Millimeter
Catheter Gauge	16 French
Lumen/Inner Diameter	5.2 Millimeter
Length	13.2 Centimeter
Outer Diameter	5.4 Millimeter
Lumen/Inner Diameter	0.9 Millimeter
Catheter Gauge	16 French
Lumen/Inner Diameter	5.2 Millimeter
Length	13.2 Centimeter
Outer Diameter	5.4 Millimeter
Lumen/Inner Diameter	0.9 Millimeter
Catheter Gauge	16 French
Lumen/Inner Diameter	5.2 Millimeter
Length	13.2 Centimeter

Operating and Storage Conditions

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
Handling Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00821329400520 [Primary]
GS1	10821329400527 [Package] Contains: 00821329400520 Package: BOX [5 Units] In Commercial Distribution

FDA Product Code

DYB	Introducer, Catheter

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	3
Public Version Date	2019-06-07
Device Publish Date	2018-01-10

On-Brand Devices [Flowguard™]

10821329500029	Valved Peelable Introducer
10821329500074	Valved Peelable Introducer
10821329500081	Valved Peelable Introducer
10821329500067	Valved Peelable Introducer
10821329500050	Valved Peelable Introducer
10821329500043	Valved Peelable Introducer
10821329500036	Valved Peelable Introducer
10821329500012	Valved Peelable Introducer
10821329400572	Valved Peelable Introducer
10821329400565	Valved Peelable Introducer
10821329400558	Valved Peelable Introducer
10821329400541	Valved Peelable Introducer
10821329400534	Valved Peelable Introducer
10821329400527	Valved Peelable Introducer
10821329400510	Valved Peelable Introducer
10821329400503	Valved Peelable Introducer
10821329400497	Valved Peelable Introducer
10821329400480	Valved Peelable Introducer
10821329400473	Valved Peelable Introducer
10821329400466	Valved Peelable Introducer
00821329400452	Valved Peelable Introducer
00821329400445	Valved Peelable Introducer
00821329400438	Valved Peelable Introducer
00821329400421	Valved Peelable Introducer
10821329400183	Valved Peelable Introducer
10821329400176	Valved Peelable Introducer
10821329400169	Valved Peelable Introducer
10821329400152	Valved Peelable Introducer
00821329400117	Valved Peelable Introducer
00821329400100	Valved Peelable Introducer
00821329400094	Valved Peelable Introducer
00821329400087	Valved Peelable Introducer

Trademark Results [Flowguard]

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