Inject8™ CCSB881/C

GUDID 10884450606619

Merit Medical Systems, Inc.

Angiographic syringe

• Primary Device ID: 10884450606619
• NIH Device Record Key: fa1c7dd2-ff66-4d28-b50b-bda94e857c8b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Inject8™
• Version Model Number: 00884450606612
• Catalog Number: CCSB881/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

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00884450606612 [Primary]
GS1	10884450606619 [Package]; Contains: 00884450606612; Package: [25 Units]; In Commercial Distribution
GS1	20884450606616 [Package]; 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: 2022-09-09
• Device Publish Date: 2022-09-01

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