SINO-K
GUDID 06972820960663
Disposable SpO2 Sensor
Shenzhen SINO-K Medical Technology Co.,Ltd
Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use| Primary Device ID | 06972820960663 |
| NIH Device Record Key | 5e6d48ef-568a-4d58-9787-0447275e4e5e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SINO-K |
| Version Model Number | SP1019A |
| 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 | false |
| 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 | 06972820960663 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K192608
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 | 2022-02-25 |
| Device Publish Date | 2022-02-17 |
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 |
Trademark Results [SINO-K]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SINO-K 97309412 not registered Live/Pending |
Shenzhen Zhongcang Medical Technology Co., Ltd. 2022-03-12 |
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