Integra Pudenz Infant Cardiac Catheter NL8501220

GUDID 10381780024255

The Infant Cardiac Catheter model is designed for ventriculoatrial shunting of CSF in children with small veins. The distal section of the catheter is reduced to approximately one-half standard diameter for easier insertion. The proximal section of the catheter contains an imbedded barium sulfate-impregnated strip, and the distal section is fully barium sulfate-impregnated. The infant model does not contain graduation markets.

Integra Lifesciences Corporation

Atrial cerebrospinal fluid catheter Atrial cerebrospinal fluid catheter Atrial cerebrospinal fluid catheter Atrial cerebrospinal fluid catheter Atrial cerebrospinal fluid catheter Atrial cerebrospinal fluid catheter Atrial cerebrospinal fluid catheter Atrial cerebrospinal fluid catheter Atrial cerebrospinal fluid catheter Atrial cerebrospinal fluid catheter Atrial cerebrospinal fluid catheter Atrial cerebrospinal fluid catheter Atrial cerebrospinal fluid catheter Atrial cerebrospinal fluid catheter Atrial cerebrospinal fluid catheter Atrial cerebrospinal fluid catheter Atrial cerebrospinal fluid catheter Atrial cerebrospinal fluid catheter Atrial cerebrospinal fluid catheter Atrial cerebrospinal fluid catheter Atrial cerebrospinal fluid catheter Atrial cerebrospinal fluid catheter Atrial cerebrospinal fluid catheter Atrial cerebrospinal fluid catheter Atrial cerebrospinal fluid catheter Atrial cerebrospinal fluid catheter Atrial cerebrospinal fluid catheter Atrial cerebrospinal fluid catheter Atrial cerebrospinal fluid catheter Atrial cerebrospinal fluid catheter Atrial cerebrospinal fluid catheter Atrial cerebrospinal fluid catheter Atrial cerebrospinal fluid catheter Atrial cerebrospinal fluid catheter Atrial cerebrospinal fluid catheter Atrial cerebrospinal fluid catheter Atrial cerebrospinal fluid catheter Atrial cerebrospinal fluid catheter Atrial cerebrospinal fluid catheter Atrial cerebrospinal fluid catheter Atrial cerebrospinal fluid catheter Atrial cerebrospinal fluid catheter Atrial cerebrospinal fluid catheter Atrial cerebrospinal fluid catheter Atrial cerebrospinal fluid catheter Atrial cerebrospinal fluid catheter Atrial cerebrospinal fluid catheter Atrial cerebrospinal fluid catheter Atrial cerebrospinal fluid catheter Atrial cerebrospinal fluid catheter Atrial cerebrospinal fluid catheter Atrial cerebrospinal fluid catheter Atrial cerebrospinal fluid catheter Atrial cerebrospinal fluid catheter Atrial cerebrospinal fluid catheter
Primary Device ID10381780024255
NIH Device Record Key0d9792db-8c8a-47a7-b87d-50d986e93a34
Commercial Distribution StatusIn Commercial Distribution
Brand NameIntegra Pudenz Infant Cardiac Catheter
Version Model NumberNL8501220
Catalog NumberNL8501220
Company DUNS083171244
Company NameIntegra Lifesciences Corporation
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com

Device Dimensions

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Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *SpeciaAvoid contaminants such as lint, fingerprints, or talc.
Special Storage Condition, SpecifyBetween 0 and 0 *SpeciaAvoid contaminants such as lint, fingerprints, or talc.
Special Storage Condition, SpecifyBetween 0 and 0 *SpeciaAvoid contaminants such as lint, fingerprints, or talc.
Special Storage Condition, SpecifyBetween 0 and 0 *SpeciaAvoid contaminants such as lint, fingerprints, or talc.
Special Storage Condition, SpecifyBetween 0 and 0 *SpeciaAvoid contaminants such as lint, fingerprints, or talc.
Special Storage Condition, SpecifyBetween 0 and 0 *SpeciaAvoid contaminants such as lint, fingerprints, or talc.
Special Storage Condition, SpecifyBetween 0 and 0 *SpeciaAvoid contaminants such as lint, fingerprints, or talc.
Special Storage Condition, SpecifyBetween 0 and 0 *SpeciaAvoid contaminants such as lint, fingerprints, or talc.
Special Storage Condition, SpecifyBetween 0 and 0 *SpeciaAvoid contaminants such as lint, fingerprints, or talc.
Special Storage Condition, SpecifyBetween 0 and 0 *SpeciaAvoid contaminants such as lint, fingerprints, or talc.
Special Storage Condition, SpecifyBetween 0 and 0 *SpeciaAvoid contaminants such as lint, fingerprints, or talc.
Special Storage Condition, SpecifyBetween 0 and 0 *SpeciaAvoid contaminants such as lint, fingerprints, or talc.
Special Storage Condition, SpecifyBetween 0 and 0 *SpeciaAvoid contaminants such as lint, fingerprints, or talc.
Special Storage Condition, SpecifyBetween 0 and 0 *SpeciaAvoid contaminants such as lint, fingerprints, or talc.
Special Storage Condition, SpecifyBetween 0 and 0 *SpeciaAvoid contaminants such as lint, fingerprints, or talc.
Special Storage Condition, SpecifyBetween 0 and 0 *SpeciaAvoid contaminants such as lint, fingerprints, or talc.
Special Storage Condition, SpecifyBetween 0 and 0 *SpeciaAvoid contaminants such as lint, fingerprints, or talc.
Special Storage Condition, SpecifyBetween 0 and 0 *SpeciaAvoid contaminants such as lint, fingerprints, or talc.
Special Storage Condition, SpecifyBetween 0 and 0 *SpeciaAvoid contaminants such as lint, fingerprints, or talc.
Special Storage Condition, SpecifyBetween 0 and 0 *SpeciaAvoid contaminants such as lint, fingerprints, or talc.
Special Storage Condition, SpecifyBetween 0 and 0 *SpeciaAvoid contaminants such as lint, fingerprints, or talc.
Special Storage Condition, SpecifyBetween 0 and 0 *SpeciaAvoid contaminants such as lint, fingerprints, or talc.
Special Storage Condition, SpecifyBetween 0 and 0 *SpeciaAvoid contaminants such as lint, fingerprints, or talc.
Special Storage Condition, SpecifyBetween 0 and 0 *SpeciaAvoid contaminants such as lint, fingerprints, or talc.
Special Storage Condition, SpecifyBetween 0 and 0 *SpeciaAvoid contaminants such as lint, fingerprints, or talc.
Special Storage Condition, SpecifyBetween 0 and 0 *SpeciaAvoid contaminants such as lint, fingerprints, or talc.
Special Storage Condition, SpecifyBetween 0 and 0 *SpeciaAvoid contaminants such as lint, fingerprints, or talc.
Special Storage Condition, SpecifyBetween 0 and 0 *SpeciaAvoid contaminants such as lint, fingerprints, or talc.
Special Storage Condition, SpecifyBetween 0 and 0 *SpeciaAvoid contaminants such as lint, fingerprints, or talc.
Special Storage Condition, SpecifyBetween 0 and 0 *SpeciaAvoid contaminants such as lint, fingerprints, or talc.
Special Storage Condition, SpecifyBetween 0 and 0 *SpeciaAvoid contaminants such as lint, fingerprints, or talc.
Special Storage Condition, SpecifyBetween 0 and 0 *SpeciaAvoid contaminants such as lint, fingerprints, or talc.
Special Storage Condition, SpecifyBetween 0 and 0 *SpeciaAvoid contaminants such as lint, fingerprints, or talc.
Special Storage Condition, SpecifyBetween 0 and 0 *SpeciaAvoid contaminants such as lint, fingerprints, or talc.
Special Storage Condition, SpecifyBetween 0 and 0 *SpeciaAvoid contaminants such as lint, fingerprints, or talc.
Special Storage Condition, SpecifyBetween 0 and 0 *SpeciaAvoid contaminants such as lint, fingerprints, or talc.
Special Storage Condition, SpecifyBetween 0 and 0 *SpeciaAvoid contaminants such as lint, fingerprints, or talc.
Special Storage Condition, SpecifyBetween 0 and 0 *SpeciaAvoid contaminants such as lint, fingerprints, or talc.
Special Storage Condition, SpecifyBetween 0 and 0 *SpeciaAvoid contaminants such as lint, fingerprints, or talc.
Special Storage Condition, SpecifyBetween 0 and 0 *SpeciaAvoid contaminants such as lint, fingerprints, or talc.
Special Storage Condition, SpecifyBetween 0 and 0 *SpeciaAvoid contaminants such as lint, fingerprints, or talc.
Special Storage Condition, SpecifyBetween 0 and 0 *SpeciaAvoid contaminants such as lint, fingerprints, or talc.
Special Storage Condition, SpecifyBetween 0 and 0 *SpeciaAvoid contaminants such as lint, fingerprints, or talc.
Special Storage Condition, SpecifyBetween 0 and 0 *SpeciaAvoid contaminants such as lint, fingerprints, or talc.
Special Storage Condition, SpecifyBetween 0 and 0 *SpeciaAvoid contaminants such as lint, fingerprints, or talc.
Special Storage Condition, SpecifyBetween 0 and 0 *SpeciaAvoid contaminants such as lint, fingerprints, or talc.
Special Storage Condition, SpecifyBetween 0 and 0 *SpeciaAvoid contaminants such as lint, fingerprints, or talc.
Special Storage Condition, SpecifyBetween 0 and 0 *SpeciaAvoid contaminants such as lint, fingerprints, or talc.
Special Storage Condition, SpecifyBetween 0 and 0 *SpeciaAvoid contaminants such as lint, fingerprints, or talc.
Special Storage Condition, SpecifyBetween 0 and 0 *SpeciaAvoid contaminants such as lint, fingerprints, or talc.
Special Storage Condition, SpecifyBetween 0 and 0 *SpeciaAvoid contaminants such as lint, fingerprints, or talc.
Special Storage Condition, SpecifyBetween 0 and 0 *SpeciaAvoid contaminants such as lint, fingerprints, or talc.
Special Storage Condition, SpecifyBetween 0 and 0 *SpeciaAvoid contaminants such as lint, fingerprints, or talc.
Special Storage Condition, SpecifyBetween 0 and 0 *SpeciaAvoid contaminants such as lint, fingerprints, or talc.
Special Storage Condition, SpecifyBetween 0 and 0 *SpeciaAvoid contaminants such as lint, fingerprints, or talc.

Device Identifiers

Device Issuing AgencyDevice ID
GS110381780024255 [Primary]
HIBCCM269NL85012201 [Secondary]

FDA Product Code

JXGShunt, central nervous system and components

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2020-09-22
Device Publish Date2016-12-15

On-Brand Devices [Integra Pudenz Infant Cardiac Catheter]

10381780072294The Infant Cardiac Catheter model is designed for ventriculoatrial shunting of CSF in children w
10381780072287The Infant Cardiac Catheter model is designed for ventriculoatrial shunting of CSF in children w
10381780024255The Infant Cardiac Catheter model is designed for ventriculoatrial shunting of CSF in children w

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