Changke Connect

GUDID 16973874210169

Set of 20pcs products in a box

Shenzhen Changke Connect Electronics Co., Ltd.

Neurophysiologic monitoring system

• Primary Device ID: 16973874210169
• NIH Device Record Key: 38e3ffbf-904d-4e20-a9cd-2cfaa715c957
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Changke Connect
• Version Model Number: P01-001-00576
• Company DUNS: 529906512
• Company Name: Shenzhen Changke Connect Electronics 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	16973874210169 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213884

FDA Product Code

• GXY: Electrode, Cutaneous

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: 2022-05-20
• Device Publish Date: 2022-05-12

On-Brand Devices [Changke Connect]

• 06973874210056: CK-SMD-982A1-05AR2
• 06973874210049: CK-SMD-582A1-05AR2
• 06973874210032: CK-SMD-A82A1-03AN2
• 06973874210025: CK-SMD-582A1-03AR2
• 06973874210018: CK-SMD-481A1-12AR2
• 16973874210138: P01-001-00573
• 16973874210121: P01-001-00572
• 16973874210114: P01-001-00571
• 16973874210107: P01-001-00570
• 06973874210261: P01-001-00578
• 06973874210131: P01-001-00565
• 06973874210124: P01-001-00564
• 06973874210117: P01-001-00563
• 06973874210100: P01-001-00562
• 06973874210094: GCF1205
• 06973874210087: GCF1203
• 06973874210070: GCF1204
• 06973874210063: GCF1202
• 06973874210001: GCF1200
• 16973874210176: Set of 20pcs products in a box
• 16973874210169: Set of 20pcs products in a box
• 16973874210152: Set of 20pcs products in a box
• 16973874210145: Set of 20pcs products in a box
• 06973874210179: P01-001-00569
• 06973874210162: P01-001-00568
• 06973874210155: P01-001-00567
• 06973874210148: P01-001-00566