BD PhaSeal 515001

GUDID 50382905150017

INJECTOR LUER N30C

BECTON DICKINSON PEN LIMITED

Luer/Luer linear connector, single-use Luer/Luer linear connector, single-use Luer/non-ISO80369-standardized linear connector, single-use Luer/non-ISO80369-standardized linear connector, single-use Luer/non-ISO80369-standardized linear connector, single-use Luer/non-ISO80369-standardized linear connector, single-use Luer/non-ISO80369-standardized linear connector, single-use Luer/non-ISO80369-standardized linear connector, single-use Luer/non-ISO80369-standardized linear connector, single-use Luer/non-ISO80369-standardized linear connector, single-use Luer/non-ISO80369-standardized linear connector, single-use Luer/non-ISO80369-standardized linear connector, single-use Luer/non-ISO80369-standardized linear connector, single-use Luer/non-ISO80369-standardized linear connector, single-use Luer/non-ISO80369-standardized linear connector, single-use Luer/non-ISO80369-standardized linear connector, single-use Luer/non-ISO80369-standardized linear connector, single-use Luer/non-ISO80369-standardized linear connector, single-use Luer/non-ISO80369-standardized linear connector, single-use Luer/non-ISO80369-standardized linear connector, single-use
Primary Device ID50382905150017
NIH Device Record Keyc8d804e4-0a13-4606-b9d6-59b261a34d3e
Commercial Distribution StatusIn Commercial Distribution
Brand NameBD PhaSeal
Version Model Number515001
Catalog Number515001
Company DUNS988402590
Company NameBECTON DICKINSON PEN LIMITED
Device Count50
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100382905150012 [Unit of Use]
GS130382905150013 [Primary]
GS150382905150017 [Package]
Contains: 30382905150013
Package: Case [4 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ONBClosed antineoplastic and hazardous drug reconstitution and transfer system

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-10-23
Device Publish Date2016-09-19

On-Brand Devices [BD PhaSeal]

50382905153070INFUSION ADAPTER C100 MULTI
30382905153069INFUSION ADAPTER C100
30382905153052L CONNECTOR C90
50382905151069PROTECTOR P50 MULTIPACK
50382905151038PROTECTOR P21 MULTIPACK
50382905150055INJECTOR LUER LOCK N35C MULTIPACK
50382905154046CAP FOR INJECTOR MEMBRANE M50
50382905153049Y-SITE CONNECTOR C80
50382905152035CONNECTOR TWIST LOCK C48
50382905152028CONNECTOR LUER LOCK C45
50382905152004CONNECTOR LUER LOCK C35
50382905151175PROTECTOR P55
50382905151076PROTECTOR P53
50382905151052PROTECTOR P50
50382905151045PROTECTOR P28
50382905151021PROTECTOR P21
50382905151007PROTECTOR P14
50382905150048INJECTOR LUER LOCK N35C
50382905150031INJECTOR LUER LOCK N35
50382905150017INJECTOR LUER N30C
30382905154066Connector Cap (M70)
30382905153021Secondary Set (C61)
50382905153018Secondary Set, Drip Chamber (C60)
50382905154039Infusion Clamp (M25)
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