N/A 306503

GUDID 50382903065030

NORMAL SALINE 3ML FILL IN 10ML SYRINGE

BECTON, DICKINSON AND COMPANY

Vascular catheter flush syringe

• Primary Device ID: 50382903065030
• NIH Device Record Key: 91849648-99db-4a9b-980e-3a74ce035106
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: N/A
• Version Model Number: 306503
• Catalog Number: 306503
• Company DUNS: 001292192
• Company Name: BECTON, DICKINSON AND COMPANY
• Device Count: 30
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00382903065035 [Unit of Use]
GS1	30382903065036 [Primary]
GS1	50382903065030 [Package]; Contains: 30382903065036; Package: Case [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K011982

FDA Product Code

• FOZ: Catheter,intravascular,therapeutic,short-term less than 30 days

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-16

On-Brand Devices [N/A]

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