Matreneu® Percutaneous Balloon Compression Kit PBCS-108013
GUDID 06939698601388
This product primarily consists of five parts, i.e. the balloon catheter, puncture needle, syringe, connector, and pressure gauge.
Shenzhen Shineyard Medical Device Co.,Ltd.
Neural-tissue balloon catheter| Primary Device ID | 06939698601388 |
| NIH Device Record Key | b5f2d093-a771-4d86-acc6-95e38ef45d1a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Matreneu® Percutaneous Balloon Compression Kit |
| Version Model Number | PBCS-108013 |
| Catalog Number | PBCS-108013 |
| Company DUNS | 544919616 |
| Company Name | Shenzhen Shineyard Medical Device 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 | true |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | true |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Operating and Storage Conditions
| Handling Environment Atmospheric Pressure | Between 86 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 86 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 86 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 86 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 86 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 86 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 86 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 86 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 86 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 86 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 86 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 86 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 86 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 86 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 86 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 86 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 86 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 86 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 86 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 86 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 86 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 86 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 86 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 86 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 86 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 86 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 86 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 86 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 86 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 86 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 86 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 86 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06939698601388 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K220920
FDA Product Code
| HAO | Instrument, Surgical, Non-Powered |
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 | 2023-06-15 |
| Device Publish Date | 2023-06-07 |
On-Brand Devices [Matreneu® Percutaneous Balloon Compression Kit]
| 06939698601494 | This product primarily consists of five parts, i.e. the balloon catheter, puncture needle, syrin |
| 06939698601487 | This product primarily consists of five parts, i.e. the balloon catheter, puncture needle, syrin |
| 06939698601470 | This product primarily consists of five parts, i.e. the balloon catheter, puncture needle, syrin |
| 06939698601463 | This product primarily consists of five parts, i.e. the balloon catheter, puncture needle, syrin |
| 06939698601456 | This product primarily consists of five parts, i.e. the balloon catheter, puncture needle, syrin |
| 06939698601449 | This product primarily consists of five parts, i.e. the balloon catheter, puncture needle, syrin |
| 06939698601432 | This product primarily consists of five parts, i.e. the balloon catheter, puncture needle, syrin |
| 06939698601425 | This product primarily consists of five parts, i.e. the balloon catheter, puncture needle, syrin |
| 06939698601418 | This product primarily consists of five parts, i.e. the balloon catheter, puncture needle, syrin |
| 06939698601401 | This product primarily consists of five parts, i.e. the balloon catheter, puncture needle, syrin |
| 06939698601395 | This product primarily consists of five parts, i.e. the balloon catheter, puncture needle, syrin |
| 06939698601388 | This product primarily consists of five parts, i.e. the balloon catheter, puncture needle, syrin |
| 06939698601364 | This product primarily consists of five parts, i.e. the balloon catheter, puncture needle, syrin |
| 06939698601357 | This product primarily consists of five parts, i.e. the balloon catheter, puncture needle, syrin |
| 06939698601340 | This product primarily consists of five parts, i.e. the balloon catheter, puncture needle, syrin |
| 06939698601333 | This product primarily consists of five parts, i.e. the balloon catheter, puncture needle, syrin |
| 06939698601326 | This product primarily consists of five parts, i.e. the balloon catheter, puncture needle, syrin |
| 06939698601302 | This product primarily consists of five parts, i.e. the balloon catheter, puncture needle, syrin |
| 06939698601296 | This product primarily consists of five parts, i.e. the balloon catheter, puncture needle, syrin |
| 06939698601289 | This product primarily consists of five parts, i.e. the balloon catheter, puncture needle, syrin |
| 06939698601272 | This product primarily consists of five parts, i.e. the balloon catheter, puncture needle, syrin |
| 06939698601265 | This product primarily consists of five parts, i.e. the balloon catheter, puncture needle, syrin |
| 06939698601258 | This product primarily consists of five parts, i.e. the balloon catheter, puncture needle, syrin |
| 06939698601241 | This product primarily consists of five parts, i.e. the balloon catheter, puncture needle, syrin |
| 06939698601234 | This product primarily consists of five parts, i.e. the balloon catheter, puncture needle, syrin |
Trademark Results [Matreneu]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MATRENEU 88513630 not registered Live/Pending |
Shenzhen Qingyuan Medical Equipment Co., Ltd. 2019-07-15 |
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