Inject10n ™ CCXB011/B

GUDID 20884450627307

Merit Medical Systems, Inc.

General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use

• Primary Device ID: 20884450627307
• NIH Device Record Key: 0d28752f-fef4-49b5-969c-151b90297f24
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Inject10n ™
• Version Model Number: 00884450627303
• Catalog Number: CCXB011/B
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00884450627303 [Primary]
GS1	10884450627300 [Package]; Contains: 00884450627303; Package: [25 Units]; In Commercial Distribution
GS1	20884450627307 [Package]; Contains: 10884450627300; Package: [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163084

FDA Product Code

• DXT: Injector and syringe, angiographic

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: 2022-05-09
• Device Publish Date: 2022-04-30

On-Brand Devices [Inject10n ™]

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