FDA.reportPublic FDA data

NA

Primary DI
00613994501035
Brand
NA
Company
MEDTRONIC, INC.
Model
6725
Device description
PIN PLUG 6725 US CONNECTOR PORT
Published
2014-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DXYimplantable pacemaker Pulse-generator
LWSImplantable cardioverter defibrillator (non-CRT)
NABGauze / sponge,nonresorbable for external use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXYImplantable Pacemaker Pulse-GeneratorCardiovascular3
LWSImplantable Cardioverter Defibrillator (Non-Crt)Unknown3
NABGauze / Sponge,Nonresorbable For External UseGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P920015054

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P920015054MEDTRONIC(R) TRANSVENE LEAD SYSTEMMedtronic, Inc.1993-12-09NVY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00613994501035PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00613994501035006139945010356139945010350613994501035

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac pulse generator port plugA device used to seal the unused connector port of an implantable pacemaker or an implantable cardioverter-defibrillator (ICD), to provide electrical isolation and protect the parent device from the extremely hostile environment of the human body when implanted. It is typically made of high-grade stainless steel and silicone, and is inserted sterile into the vacant port (e.g., an IS-1 connection). This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
006261481
Device count
1
Lot or batch
true

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Primary DIBrandModelCatalogPublished
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00199150083442NABB5G97R132026-05-30
00199150083534NABB10U10R172026-05-30
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00199150083763NA7J79R92026-05-30
00199150083794NABB8P50R62026-05-30
00199150083800NABB12E50R62026-05-30
00199150083817NABB10Z66R152026-05-30
00199150083893NA7E60R32026-05-30
00199150083985NABB12V61R12026-05-30
00199309002416N/ATH91DBS2026-05-29
00613994964120Sones™ Brachial9907072016-06-05
00613994964748Goodale-Lubin™0074602016-06-05
00199150006038N/ATM91D02026-05-23
00199150080649NABB12S94R52026-05-23
00199150080694NABB12V43R12026-05-23

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