FDA.report

Port Access Needle

Primary DI
10801741037563
Brand
Port Access Needle
Company
Bard Access Systems, Inc.
Model
0604170
Catalog number
0604170
Device description
Winged Infusion Set 19G x 0.75 inch
Published
2016-09-16
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
FMINeedle, hypodermic, single lumen

Product Code Classifications

CodeDeviceSpecialtyClass
FMINeedle, Hypodermic, Single LumenGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10801741037563PackageGS120In Commercial Distribution
20801741037560PackageGS112In Commercial Distribution
00801741037566PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1080174103756310801741037563
2080174103756020801741037560
00801741037566008017410375668017410375660801741037566

GMDN Terms

TermDefinition
Vascular port administration setA collection of devices designed to conduct fluids from an intravenous (IV) fluid container to a patient's venous system via a previously implanted injection/infusion port. It typically includes a noncoring needle designed with a lateral hole (side-hole), tubing, connectors, chambers, clamps and may include an injection placement aid. This is a single-use device.

Device Sizes

TypeValueUnit
Needle Gauge19Gauge

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)545-0890medical.services@crbard.com

Regulatory Flags

DUNS number
044611812
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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