Inject10n ™

GUDID 10884450012267

Merit Medical Systems, Inc.

Anaesthesia conduction catheter holder, sterile Anaesthesia conduction catheter holder, sterile Anaesthesia conduction catheter holder, sterile Anaesthesia conduction catheter holder, sterile Anaesthesia conduction catheter holder, sterile Anaesthesia conduction catheter holder, sterile Anaesthesia conduction catheter holder, sterile Anaesthesia conduction catheter holder, sterile Anaesthesia conduction catheter holder, sterile Anaesthesia conduction catheter holder, sterile Anaesthesia conduction catheter holder, sterile Anaesthesia conduction catheter holder, sterile Anaesthesia conduction catheter holder, sterile Anaesthesia conduction catheter holder, sterile Anaesthesia conduction catheter holder, sterile Anaesthesia conduction catheter holder, sterile Anaesthesia conduction catheter holder, sterile

• Primary Device ID: 10884450012267
• NIH Device Record Key: 41886540-15cf-4e62-ba98-41bf4e572871
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Inject10n ™
• Version Model Number: 00884450012260
• Company DUNS: 184763290
• Company Name: Merit Medical Systems, Inc.
• 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: false
• OTC Over-The-Counter: false

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884450012260 [Primary]
GS1	10884450012267 [Package]; Contains: 00884450012260; Package: [25 Units]; In Commercial Distribution
GS1	20884450012264 [Package]; Package: [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K875196

FDA Product Code

• FMF: Syringe, piston

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: 2016-09-24

On-Brand Devices [Inject10n ™]

• 10884450027841: 00884450027844
• 10884450027834: 00884450027837
• 10884450021320: 00884450021323
• 10884450012267: 00884450012260
• 10884450606718: 00884450606711
• 20884450627307: 00884450627303
• 10884450606701: 00884450606704