FDA.reportPublic FDA data

AMPLATZER™

Primary DI
00811806014111
Brand
AMPLATZER™
Company
AGA MEDICAL CORPORATION
Model
9-TV45X45-14F-100
Catalog number
9-TV45X45-14F-100
Device description
Delivery Sheath
Published
2015-03-09
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
DQYCATHETER, PERCUTANEOUS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQYCatheter, PercutaneousCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00811806014111PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811806014111008118060141118118060141110811806014111

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac occluder delivery kitA collection of sterile devices designed to implant a cardiac occluder for the non-surgical closure of cardiac defects. The collection may include a delivery catheter/sheath, dilator, loading device, delivery cable, and additional items for the intravascular delivery and deployment of a cardiac occlude; the cardiac occluder is not included. The devices are used in the treatment of cardiac disorders that may include (but not limited to) atrial septal defects (ASD), ventricular septal defects (VSD), patent foramen ovale (PFO), or patent ductus arteriosus (PDA). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge14French

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00STORE IN A DRY PLACE.
Special Storage Condition, Specify00STORE IN DRY PLACE.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(855)478-5833customerservice@sjm.com

Regulatory Flags#

DUNS number
966215829
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05415067019127Amplatzer™9-ASD-0049-ASD-0042015-01-27
05415067019134AMPLATZER™9-ASD-0059-ASD-0052015-01-27
05415067019141AMPLATZER™9-ASD-0069-ASD-0062015-01-27
05415067019158AMPLATZER™9-ASD-0079-ASD-0072015-01-27
05415067019165AMPLATZER™9-ASD-0089-ASD-0082015-01-27
05415067019172AMPLATZER™9-ASD-0099-ASD-0092015-01-27
05415067019189AMPLATZER™9-ASD-0109-ASD-0102015-01-27
05415067019196AMPLATZER™9-ASD-0119-ASD-0112015-01-27
05415067019202AMPLATZER™9-ASD-0129-ASD-0122015-01-27
05415067019219Amplatzer™9-ASD-0139-ASD-0132015-01-27
05415067019226Amplatzer™9-ASD-0149-ASD-0142015-01-27
05415067019233Amplatzer™9-ASD-0159-ASD-0152015-01-27
05415067019240Amplatzer™9-ASD-0169-ASD-0162015-01-27
05415067019257Amplatzer™9-ASD-0179-ASD-0172015-01-27
05415067019264Amplatzer™9-ASD-0189-ASD-0182015-01-27
05415067019271Amplatzer™9-ASD-0199-ASD-0192015-01-27
05415067019288Amplatzer™9-ASD-0209-ASD-0202015-01-27
05415067019295Amplatzer™9-ASD-0229-ASD-0222015-01-27
05415067019301Amplatzer™9-ASD-0249-ASD-0242015-01-27
05415067019318Amplatzer™9-ASD-0269-ASD-0262015-01-27

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Primary DI, Brand, Company table
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08718122013984Primum Guiding CatheterPendraCare International B.V.DQY2026-02-02
08718122028896Primum Guiding CatheterPendraCare International B.V.DQY2026-02-02
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10841156111250GUIDELINERTELEFLEX INCORPORATEDDQY2025-07-14
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10801902217773ARROWTELEFLEX INCORPORATEDDQY2024-04-08
10801902217988ARROWTELEFLEX INCORPORATEDDQY2024-03-18
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