Inject8™ CCSW880/C

GUDID 20884450606685

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

• Primary Device ID: 20884450606685
• NIH Device Record Key: e8874cc5-1837-455d-8ec9-86c7afd01ef0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Inject8™
• Version Model Number: 00884450606681
• Catalog Number: CCSW880/C
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00884450606681 [Primary]
GS1	10884450606688 [Package]; Contains: 00884450606681; Package: [25 Units]; In Commercial Distribution
GS1	20884450606685 [Package]; Contains: 10884450606688; 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: 2022-09-07
• Device Publish Date: 2022-08-30

On-Brand Devices [Inject8™]

• 10884450030315: 00884450030318
• 20884450025400: 00884450025406
• 20884450024564: 00884450024560
• 10884450021313: 00884450021316
• 10884450021276: 00884450021279
• 20884450011953: 00884450011959
• 10884450606503: 00884450606506
• 10884450606527: 00884450606520
• 20884450606685: 00884450606681
• 10884450606619: 00884450606612
• 10884450606602: 00884450606605