Double Dove 0200

GUDID 06934755702008

Sterile hypodermic syringe for single use, with needle, is intended to be used for medical purposes to inject fluid into or withdraw fluid from the body. Volume: 1mL; Needle size: 0.45*12.7mm RWLB; Nozzle type: Luer Lock.

Jumin Bio-Technologies, Co., Ltd.

General-purpose syringe/needle

• Primary Device ID: 06934755702008
• NIH Device Record Key: b01dcb5a-6407-4f88-8d2f-b6dcbe478c3b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Double Dove
• Version Model Number: 0200
• Catalog Number: 0200
• Company DUNS: 544382151
• Company Name: Jumin Bio-Technologies, Co., Ltd.
• 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: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06934755702008 [Primary]
GS1	16934755702005 [Package]; Package: shelf carton [100 Units]; In Commercial Distribution
GS1	26934755702002 [Package]; Contains: 16934755702005; Package: case carton [30 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090929

FDA Product Code

• FMF: Syringe, Piston

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: 2021-02-08
• Device Publish Date: 2021-01-29

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• 16934755702050: Sterile hypodermic syringe for single use, with needle, is intended to be used for medical purpo
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• 06934755702022: Sterile hypodermic syringe for single use, with needle, is intended to be used for medical purpo
• 06934755702008: Sterile hypodermic syringe for single use, with needle, is intended to be used for medical purpo