N/A 306503

GUDID 50382903065030

NORMAL SALINE 3ML FILL IN 10ML SYRINGE

BECTON, DICKINSON AND COMPANY

Vascular catheter flush syringe
Primary Device ID50382903065030
NIH Device Record Key91849648-99db-4a9b-980e-3a74ce035106
Commercial Distribution StatusIn Commercial Distribution
Brand NameN/A
Version Model Number306503
Catalog Number306503
Company DUNS001292192
Company NameBECTON, DICKINSON AND COMPANY
Device Count30
DM Exempttrue
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

Operating and Storage Conditions

Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100382903065035 [Unit of Use]
GS130382903065036 [Primary]
GS150382903065030 [Package]
Contains: 30382903065036
Package: Case [4 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FOZCatheter,intravascular,therapeutic,short-term less than 30 days

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-16

On-Brand Devices [N/A]

00382906583673CD10 PE (MEM-78) ASR
00382906581723CD123 APC (9F5) ASR
00382906563118CD22 PerCP-Cy5.5 (S-HCL-1) ASR
00382906561596IREM-2 APC (UP-H2) ASR
00382906561572Anti-Lambda APC-H7 ASR
00382906561541CD81 APC-H7 (JS-81) ASR
00382906561534CD49d APC-H7 (9F10) ASR
00382906561527CD36 FITC CLB-IVC7 ASR
00382906561503CD24 APC-H7 (ML5) ASR
00382906561497CD23 FITC EBVCS-5 ASR
00382906561473CD16 FITC CLB-Fc-gran/1 5D2 ASR
00382906561459CD11c PerCP-Cy5.5 (B-ly6) ASR
00382906560506CD38 PerCP-CyTM5.5 ASR
00382906559333IFN GAMMA APC (25723.11) ASR
00382906557353CD200 PE-Cy7 MRC OX-104 ASR
00382906557346CD28 PerCP-Cy.5.5(L293) ASR
00382906554376CD13 APC WM15 ASR
00382906554352B2-Microglobulin PerCP-cy5.5 ASR
00382906554345TCR gamma/delta-1 PE-Cy7 (11F2) ASR
00382906554338CD9 APC-H7 ASR
00382906554321CD79b PerCP-Cy5.5 SN8 ASR
00382906554314CD71 APC-H7 M-A712 ASR
00382906554307CD43 APC-H7 (1G10) ASR
00382906554291CD27 PerCP-Cy5.5 (L128) ASR
00382906554284CD200 APC (MRC OX-104) ASR
00382906554260CD10 APC-H7 (HI10A) ASR
00382906551603CD45RO FITC
00382906551580CD43 FITC
00382906551573CD27 PE-Cy7 ASR
00382906551559CD24 PE
00382906551542CD24 FITC
00382906550194CD27 APC (L128) ASR
00382906549761CD62P PE (AC1.2) ASR
00382906549754CD69 PE(L78) ASR
00382906546661CD62L PE (SK11) ASR
00382906546654CD27PE (L128) ASR
00382906546647CD27 FITC (L128) ASR
00382906546630CD69 APC (L78) ASR
00382906533142CD38 APC-H7 (HB7) ASR
00382906533128CD7 APC (M-T701) ASR
00382906523594CD11c PE-Cy7 (B-ly6) ASR
00382906494603CD45RO APC (UCHL1) ASR
00382906494597CD45RO PE (UCHL1) ASR
00382906494580CD45RA(L48) FITC ASR
00382906494573CD45RA (L48) PE-Cy7
00382906494566CD26 FITC (L272) ASR
00382906494559CD26 PE (L272) ASR
00382906494542CD58 PE (L306.4) ASR
00382906494535CD123PE (9F5) ASR
00382906494528CD45RO PE-Cy7 (UCHL1) ASR

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