FDA.report

AllPoints Port Access System PowerLoc

Primary DI
30801741232429
Brand
AllPoints Port Access System PowerLoc
Company
Bard Access Systems, Inc.
Model
AN672010M
Catalog number
AN672010M
Device description
AllPoints Port Access System PowerLoc 20G x 1 inch with Y-Site
Published
2024-12-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
LJTPORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Product Code Classifications

CodeDeviceSpecialtyClass
LJTPort & Catheter, Implanted, Subcutaneous, IntravascularGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
30801741232429PackageGS110In Commercial Distribution
00801741232428PrimaryGS10

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
Length1Inch
Needle Gauge20Gauge

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature20 Degrees Celsius25 Degrees Celsius

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
true
Combination product
true
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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