FDA.report

PED Goodale-Lubin™

Primary DI
20763000200101
Brand
PED Goodale-Lubin™
Company
MEDTRONIC, INC.
Model
990201
Device description
WVN CATH 990201 10PK 5F 100CM GOODLE LB
Published
2019-02-03
Public version status
New
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
DQOCATHETER, INTRAVASCULAR, DIAGNOSTIC

Product Code Classifications

CodeDeviceSpecialtyClass
DQOCatheter, Intravascular, DiagnosticCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20763000200101PackageGS110In Commercial Distribution
00763000200107PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
2076300020010120763000200101
00763000200107007630002001077630002001070763000200107

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
Length100Centimeter
Lumen/Inner Diameter0.889Millimeter

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Store catheters in a cool, dry area.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags

DUNS number
006261481
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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00763000823597NAHY11N74R142023-01-14
00763000823795NAHY12A49R12023-01-15

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