JZIKI

GUDID 06922119300748

ShenZhen ZhengKang Technology Co., Ltd.

Pulse oximeter

• Primary Device ID: 06922119300748
• NIH Device Record Key: 19287bf5-3136-4cc4-b02c-86aec421fa0d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: JZIKI
• Version Model Number: JZK-305
• Company DUNS: 530875902
• Company Name: ShenZhen ZhengKang Technology Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06922119300748 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213984

FDA Product Code

• DQA: Oximeter

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-05-05
• Device Publish Date: 2023-04-27

On-Brand Devices [JZIKI]

• 06922119300151: ZK-B872
• 06922119300144: ZK-B869
• 06922119300137: ZK-B868
• 06922119300120: ZK-B876
• 06922119300755: JZK-307
• 06922119300748: JZK-305
• 06922119300731: JZK-303
• 06922119300724: JZK-301
• 06922119300915: ZK-B876