Procedure Products Lines

Primary DI
B160B48F0711
Brand
Procedure Products Lines
Company
PROCEDURE PRODUCTS, INC.
Model
B48-F071
Device description
Fixed, braided, high-pressure connector
Published
2018-06-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DQOCatheter, Intravascular, Diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQOCatheter, Intravascular, DiagnosticCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K914128000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K914128000CONNECTING SETProcedure Products, Inc.1991-11-27DQO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B160B48F0711PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Intravenous line recessed-needle connectorA sterile device designed to allow access to either the Y-site of an intravenous (IV) line or an injection adaptor on the infusion catheter. Typically, a needle located inside a plastic housing can be inserted into a standard septum and a Luer fitting located at the opposite end allows the connection of a syringe or infusion set. A manual or automated mechanism moves the housing to protect the operator from the needle once the infusion is finished. The device is intended to eliminate an exposed needle after administration of medications. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
151507563
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B1602118351Procedure Products Needles21-18352017-02-07
B1602293571Procedure Products needles229-3572017-04-03
B1603118221Procedure Products Needle31-18222017-02-07
B1603293551Procedure Products needles329-3552017-04-03
B1603293571Procedure Products Needle329-3572016-12-01
B1603118451Procedure Products Needle31-18452020-03-10
B1602018221Procedure Products needles20-18222017-04-03
B1602018271Procedure Products Needle20-18272016-12-01
B1602018401Procedure Products Needles20-184020-18402018-01-02
B1602118271Procedure Products Needle21-18272016-12-01
B160211827P1Procedure Products Needles21-1827-P2017-09-27
B1603118151Procedure Products Needles31-18152017-02-07
B1603118271Procedure Products Needle31-18272016-12-01
B160311827P1Procedure Products Needles31-1827-P2017-09-27
B1603118351Procedure Products Syringes31-18352017-02-07
B1603118601Procedure Products Needle31-186031-18602018-01-02
B1603121151Procedure Products Needle31-21152017-09-12
B16032M18601Procedure Products Needle32M-18602017-02-07
B1605118271Procedure Products Needle51-18272016-12-01
B1605518291Procedure Products Needles55-182955-18292018-01-02

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