FDA.report

ARROW

Primary DI
40801902004374
Brand
ARROW
Company
TELEFLEX INCORPORATED
Model
IPN000057
Catalog number
AI-07035
Device description
CATH PKGD: REVERSE BERMAN 5 FR 80CM
Published
2016-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does n
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
DYGCATHETER, FLOW DIRECTED

Product Code Classifications

CodeDeviceSpecialtyClass
DYGCatheter, Flow DirectedCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
40801902004374PackageGS11In Commercial Distribution
60801902004378PackageGS15In Commercial Distribution
00801902004376PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
4080190200437440801902004374
6080190200437860801902004378
00801902004376008019020043768019020043760801902004376

GMDN Terms

TermDefinition
Angiographic catheter, single-useA thin, flexible tube designed to inject a contrast medium into select blood vessels of the cerebral, visceral, or peripheral vasculature during an angiographic procedure in order to facilitate the clear visualization of the vascular system of a targeted organ or area of the body. It is introduced percutaneously, has a radiopaque marker(s) for positioning, and may include disposable devices dedicated to catheter introduction/function [e.g., sheath(s)]. It may also be used for simultaneous pressure measurements to determine the transvalvular, intravascular, and intraventricular pressure gradients. This is a single-use device.

Device Sizes

TypeValueUnit
Catheter Gauge5French
Length80Centimeter

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Store at normal room temperature away from direct exposure to light. Prolonged exposure to fluorescent light, sunlight or heat will damage the balloon

Sterilization Methods

Method

Contacts

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

Regulatory Flags

DUNS number
002348191
Device count
1
DM exempt
false
Premarket exempt
true
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
true
No natural rubber latex
false
Sterilization required before use
false

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