FDA.report

Port Access Kit

Primary DI
10801741095778
Brand
Port Access Kit
Company
Bard Access Systems, Inc.
Model
2672215G
Catalog number
2672215G
Device description
PowerLoc PAK 22G x 1.5 Y-site with GuardIVa
Published
2016-02-25
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
FPASet, administration, intravascular

Product Code Classifications

CodeDeviceSpecialtyClass
FPASet, Administration, IntravascularGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10801741095778PackageGS15In Commercial Distribution
00801741095771PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1080174109577810801741095778
00801741095771008017410957718017410957710801741095771

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 Gauge22Gauge

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 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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00801741045158Niagara Slim-Cath catheter543415054341502015-11-06
10801741231275CentroVena One1K0R72161K0R72162026-01-23
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10801741231305CentroVena One1K0R73161K0R73162026-01-23
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