FDA.report

Armada

Primary DI
08717648154805
Brand
Armada
Company
ABBOTT VASCULAR INC.
Model
B1070-080
Catalog number
B1070-080
Device description
Armada 35 PTA Catheter 7 mm x 80 mm x 80 cm / Over-The-Wire
Published
2016-01-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
DQYCATHETER, PERCUTANEOUS

Product Code Classifications

CodeDeviceSpecialtyClass
DQYCatheter, PercutaneousCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08717648154805PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08717648154805087176481548058717648154805

GMDN Terms

TermDefinition
Peripheral angioplasty balloon catheter, basicA sterile, non-drug-eluting, flexible tube designed for percutaneous transluminal angioplasty (PTA) to dilate a stenotic peripheral (i.e., non-cerebral, non-coronary) artery by controlled inflation of a distensible balloon(s) at its distal tip; it may also be intended for positioning and expansion of a stent/stent-graft. It is available as an over-the-wire (OTW) type with multiple lumens, or a rapid exchange (RX) type with a single lumen. Some types may include cutting/scoring elements (e.g., microsurgical blades, dual wire configurations) to score/modify the plaque. This is a single-use device.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature59 Degrees Fahrenheit86 Degrees Fahrenheit

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)227-9902AV.CUSTOMERCARE@AV.ABBOTT.COM

Regulatory Flags

DUNS number
964569052
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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08717648353680Esprit™Esprit™1212350-282025-07-10
08717648353703Esprit™Esprit™1212350-382025-07-10
08717648353741Esprit™Esprit™ 1212375-182025-07-10
08717648353789Esprit™Esprit™1212375-382025-07-10
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08717648353864Esprit™Esprit™1212250-382025-07-10
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08717648354021Esprit™Esprit™1212300-382025-07-10
08717648356704XACT™83024-0183024-012025-04-17
08717648356742XACT™ 83022-0183022-012025-04-17
08717648356766XACT™83020-0183020-012025-04-17
08717648356803XACT™83026-0183026-012025-04-17
08717648356810HI-TORQUE COMMAND™ 106000110600012024-11-21
08717648356827HI-TORQUE COMMAND™ 1060001A1060001A2024-11-21
08717648356834HI-TORQUE COMMAND™106000210600022024-11-21
08717648356841HI-TORQUE COMMAND™ 1060002A1060002A2024-11-21

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