Amphirion Plus

Primary DI
08033477034690
Brand
Amphirion Plus
Company
MEDTRONIC, INC.
Model
AHU025080152
Device description
Cath AHU025080152plusUS 02.50 L80 UL1500
Published
2016-04-15
Public version status
Update
Distribution status
Not 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
LITCatheter, angioplasty, peripheral, transluminal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LITCatheter, Angioplasty, Peripheral, TransluminalCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K121265000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121265000AMPHIRION PLUS PTA CATHETERMedtronic, Inc.2012-05-22LIT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08033477034690PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08033477034690080334770346908033477034690

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length80Millimeter
Outer Diameter2.5Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store at controlled room temperature, in a dry place. Keep away from sunlight. Do not expose to organic solvents (such as alcohol), ionizing radiation, or ultraviolet light.

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 DI, Brand, Company table
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