MedSource Catheters Not Applicable

GUDID 00840155409736

TrueSafe Comfort with Venapur, Blood Control 20G x 1.88”

MEDSOURCE INTERNATIONAL LLC

Intravenous line recessed-needle connector

• Primary Device ID: 00840155409736
• NIH Device Record Key: 789c06e1-96d0-43ba-b24e-e0aeb4886856
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MedSource Catheters
• Version Model Number: MS-864202
• Catalog Number: Not Applicable
• Company DUNS: 041674552
• Company Name: MEDSOURCE INTERNATIONAL LLC
• Device Count: 1
• DM Exempt: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840155409729 [Primary]
GS1	00840155409736 [Package]; Contains: 00840155409729; Package: Box [50 Units]; In Commercial Distribution
GS1	00840155409743 [Package]; Contains: 00840155409729; Package: Case [200 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161779

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-07-12
• Device Publish Date: 2021-07-02

On-Brand Devices [MedSource Catheters]

• 00840155408791: PurSafe Passive Safety Catheter 24G x 0.75"
• 00840155408760: PurSafe Passive Safety Catheter 22G x 1"
• 00840155408739: PurSafe Passive Safety Catheter 20G x 1 1"
• 00840155408708: PurSafe Passive Safety Catheter 20G x 1.3"
• 00840155408678: PurSafe Passive Safety Catheter 18G x 1.25"
• 00840155408647: PurSafe Passive Safety Catheter 18G x 1.77"
• 00840155408616: PurSafe Passive Safety Catheter 16G x 1.77"
• 00840155409798: TrueSafe Comfort with Venapur, Blood Control 24G x 0.75”
• 00840155409767: TrueSafe Comfort with Venapur, Blood Control 22G x 1”
• 00840155409736: TrueSafe Comfort with Venapur, Blood Control 20G x 1.88”
• 00840155409705: TrueSafe Comfort with Venapur, Blood Control 20G x 1.16”
• 00840155409675: TrueSafe Comfort with Venapur, Blood Control 18G x 1.88”
• 00840155409644: TrueSafe Comfort with Venapur, Blood Control 18G x 1.16”
• 00840155409620: TrueSafe Comfort with Venapur, Blood Control 16G x 1.77”
• 00840155409583: TrueSafe Blood Control 24G x 0.75”
• 00840155409552: TrueSafe Blood Control 22G x 1”
• 00840155409521: TrueSafe Blood Control 20G x 1.88”
• 00840155409491: TrueSafe Blood Control 20G x 1.16”
• 00840155409460: TrueSafe Blood Control 18G x 1.88”
• 00840155409439: TrueSafe Blood Control 18G x 1.16”
• 00840155409385: TrueSafe Blood Control 16G x 1.77”
• 00840155409347: ClearSafe Comfort Blood Control 24G x 0.75”
• 00840155409316: ClearSafe Comfort Blood Control 22G x 1”
• 00840155409286: ClearSafe Comfort Blood Control 20G x 1”
• 00840155409255: ClearSafe Comfort Blood Control 20G x 1.25”
• 00840155409224: ClearSafe Comfort Blood Control 18G x 1.25”
• 00840155409194: ClearSafe Comfort Blood Control 16G x 1.25”
• 00840155409163: ClearSafe Blood Control 24G x 0.75
• 00840155409132: ClearSafe Blood Control 22G x 1”
• 00840155409101: ClearSafe Blood Control 20G x 1"
• 00840155409071: ClearSafe Blood Control 20G x 1.25”
• 00840155409040: ClearSafe Blood Control 18G x 1.25”
• 00840155409019: ClearSafe Blood Control 16G x 1.25”
• 00840155413252: TrueSafe Comfort BC IV Catheter 20G- 1"
• 00840155413221: TrueSafe Comfort BC IV Catheter 16G- 1.16"
• 00840155413191: TrueSafe Comfort BC IV Catheter 14G- 1.75''
• 00840155412538: ClearSafe Comfort Blood Control 14G x 1.25" pur
• 00840155411500: TrueSafe Comfort 24G x 0.56"
• 00840155413962: ClearSafe Comfort Closed System Dual Port 20Gx1
• 00840155413931: ClearSafe Comfort Closed System Dual Port 24Gx0.75
• 00840155413900: ClearSafe Comfort Closed System Dual Port 22Gx1
• 00840155413870: ClearSafe Comfort Closed System Dual Port 20Gx1.25
• 00840155406179: ClearSafe Comfort Closed System Dual Port 16Gx1.25
• 00840155401419: ClearSafe Comfort Closed System Dual Port 14Gx1.25