MF SAFECATH Intravascular catheter 18Gx1.88"

GUDID 28800055100382

Medifirst co., ltd.

Peripheral vascular infusion catheter Peripheral vascular infusion catheter Peripheral vascular infusion catheter Peripheral vascular infusion catheter Peripheral vascular infusion catheter Peripheral vascular infusion catheter Peripheral vascular infusion catheter Peripheral vascular infusion catheter Peripheral vascular infusion catheter Peripheral vascular infusion catheter Peripheral vascular infusion catheter Peripheral vascular infusion catheter Peripheral vascular infusion catheter Peripheral vascular infusion catheter Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter

• Primary Device ID: 28800055100382
• NIH Device Record Key: ccd59fb5-e859-43da-9ac3-085b92965fcc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MF SAFECATH
• Version Model Number: SS208
• Catalog Number: Intravascular catheter 18Gx1.88"
• Company DUNS: 688303694
• Company Name: Medifirst co., ltd.
• Device Count: 50
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800055100388 [Unit of Use]
GS1	18800055100385 [Primary]
GS1	28800055100382 [Package]; Contains: 18800055100385; Package: Case [200 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192230

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: 2020-08-18
• Device Publish Date: 2020-08-10

On-Brand Devices [MF SAFECATH]

• 28800055100467: SC110
• 28800055100450: SS201
• 28800055100443: SS202
• 28800055100436: SS203
• 28800055100429: SS204
• 28800055100412: SS205
• 28800055100405: SS206
• 28800055100399: SS207
• 28800055100382: SS208
• 28800055100375: SC101
• 28800055100368: SC102
• 28800055100351: SC103
• 28800055100344: SC104
• 28800055100337: SC105
• 28800055100320: SC106
• 28800055100313: SC107
• 28800055100306: SC108
• 28800055100290: SC109