FDA.report

ARROW

Primary DI
20801902129233
Brand
ARROW
Company
TELEFLEX INCORPORATED
Model
IPN035976
Catalog number
VPS-G4C
Device description
VPS G4(TM) Base Unit and Interface with Accessories
Published
2017-09-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
OBJCatheter, ultrasound, intravascular

Product Code Classifications

CodeDeviceSpecialtyClass
OBJCatheter, Ultrasound, IntravascularCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20801902129233Direct MarkingGS10
30801902129230PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2080190212923320801902129233
3080190212923030801902129230

GMDN Terms

TermDefinition
Intravascular ultrasound imaging catheter, single-useA flexible, non-steerable tube with an ultrasound imaging transducer enclosed in a fluid-resistant or waterproof acoustically- and electrically-insulated housing, designed for insertion into the vascular system (i.e., peripheral vascular system, coronary artery) by an operator; it is not intended for intracardial insertion/imaging. Also known as a vascular ultrasound transducer, it includes either a single or an array of transducer element(s) (piezoelectric, active, or crystal); it cannot be manoeuvred via controls (i.e., non-steerable). This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(919)544-8000CS@TELEFLEX.COM

Regulatory Flags

DUNS number
002348191
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
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
true
Sterilization required before use
false

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20841156104037SUPERCROSS530753072026-03-23
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30841156104058SUPERCROSS530953092026-03-23
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24026704941500PILLINGP12805P128052026-03-23
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