SINO-K

GUDID 06972820961509

Disposable NIBP Cuff, child, 15.8cm~21.3cm

Shenzhen SINO-K Medical Technology Co.,Ltd

Blood pressure cuff, single-use

• Primary Device ID: 06972820961509
• NIH Device Record Key: fa448cd4-ff39-4de3-a374-b13497a76d28
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SINO-K
• Version Model Number: SC0109
• Company DUNS: 554477241
• Company Name: Shenzhen SINO-K Medical Technology 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06972820961509 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231961

FDA Product Code

• DXQ: Blood Pressure Cuff

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: 2023-09-13
• Device Publish Date: 2023-09-05

On-Brand Devices [SINO-K]

• 06972820963787: Disposable SpO2 Sensor
• 06972820963770: ECG/EKG cable and lead-wires
• 06972820963763: ECG/EKG cable and lead-wires
• 06972820963756: ECG/EKG cable and lead-wires
• 06972820963749: ECG/EKG cable and lead-wires
• 06972820963732: ECG/EKG cable and lead-wires
• 06972820963725: ECG/EKG cable and lead-wires
• 06972820963718: ECG/EKG cable and lead-wires
• 06972820963701: ECG/EKG cable and lead-wires
• 06972820963695: ECG/EKG cable and lead-wires
• 06972820963688: ECG/EKG cable and lead-wires
• 06972820963671: ECG/EKG cable and lead-wires
• 06972820963664: ECG/EKG cable and lead-wires
• 06972820960755: Disposable SpO2 Sensor
• 06972820960748: Disposable SpO2 Sensor
• 06972820960731: Disposable SpO2 Sensor
• 06972820960724: Disposable SpO2 Sensor
• 06972820960717: Disposable SpO2 Sensor
• 06972820960700: Disposable SpO2 Sensor
• 06972820960687: Disposable SpO2 Sensor
• 06972820960670: Disposable SpO2 Sensor
• 06972820960663: Disposable SpO2 Sensor
• 06972820960656: Disposable SpO2 Sensor
• 06972820961295: Body cavity Temperature Probe, Esophageal, adult, disposable
• 06972820961288: Skin contact Temperature Probe, adult, disposable
• 06972820961110: Body cavity Temperature Probe, Esophageal, pediatric, reusable
• 06972820961103: Skin contact Temperature Probe, pediatric, reusable
• 06972820961097: Body cavity Temperature Probe, Esophageal, adult, reusable
• 06972820961080: Skin contact Temperature Probe, adult, reusable
• 06972820967525: Reusable NIBP Cuff, child, 18cm~26cm
• 06972820967518: Reusable NIBP Cuff, infant, 10cm~19cm
• 06972820967488: Disposable NIBP Cuff, neonate, 7cm~13cm
• 06972820967457: Disposable NIBP Cuff, neonate, 4cm~8cm
• 06972820963893: Reusable NIBP Cuff, adult, 33cm~47cm
• 06972820963497: Disposable NIBP Cuff, neonate, 6cm~11cm
• 06972820963459: Disposable NIBP Cuff, neonate, 8cm~15cm
• 06972820963442: Disposable NIBP Cuff, neonate, 3cm~6cm
• 06972820961691: Reusable NIBP Cuff, small adult, 25cm~35cm
• 06972820961530: Disposable NIBP Cuff, large adult, 32.1cm~43.4cm
• 06972820961523: Disposable NIBP Cuff, adult, 25.3cm~34.3cm
• 06972820961516: Disposable NIBP Cuff, small adult, 20cm~27cm
• 06972820961509: Disposable NIBP Cuff, child, 15.8cm~21.3cm
• 06942108005560: Disposable NIBP Cuff, small child, 12.4cm~16.8cm
• 06942108005553: Disposable NIBP Cuff, infant, 9.8cm~13.3cm
• 06942108005546: Disposable NIBP Cuff, neonate, 7.7cm~10.5cm
• 06972820963602: Reusable NIBP Cuff, neonate, 6cm~11cm