GastriSail GPS40
GUDID 20884521517384
Gastric Positioning System
Covidien LP
Gastric calibration tube, non-sterile Gastric calibration tube, non-sterile Gastric calibration tube, non-sterile Gastric calibration tube, non-sterile Gastric calibration tube, non-sterile Gastric calibration tube, non-sterile Gastric calibration tube, non-sterile Gastric calibration tube, non-sterile Gastric calibration tube, non-sterile Gastric calibration tube, non-sterile Gastric calibration tube, non-sterile Gastric calibration tube, non-sterile Gastric calibration tube, non-sterile Gastric calibration tube, non-sterile Gastric calibration tube, non-sterile Gastric calibration tube, non-sterile Gastric calibration tube, non-sterile Gastric calibration tube, non-sterile Gastric calibration tube, non-sterile Gastric calibration tube, non-sterile Gastric calibration tube, non-sterile Gastric calibration tube, non-sterile Gastric calibration tube, non-sterile Gastric calibration tube, non-sterile Gastric calibration tube, non-sterile Gastric calibration tube, non-sterile Gastric calibration tube, non-sterile Gastric calibration tube, non-sterile Gastric calibration tube, non-sterile Gastric calibration tube, non-sterile Gastric calibration tube, non-sterile Gastric calibration tube, non-sterile Gastric calibration tube, non-sterile Gastric calibration tube, non-sterile Gastric calibration tube, non-sterile Gastric calibration tube, non-sterile Gastric calibration tube, non-sterile Gastric calibration tube, non-sterile Gastric calibration tube, non-sterile Gastric calibration tube, non-sterile Gastric calibration tube, non-sterile Gastric calibration tube, non-sterile Gastric calibration tube, non-sterile Gastric calibration tube, non-sterile Gastric calibration tube, non-sterile Gastric calibration tube, non-sterile Gastric calibration tube, non-sterile Gastric calibration tube, non-sterile Gastric calibration tube, non-sterile Gastric calibration tube, non-sterile Gastric calibration tube, non-sterile Gastric calibration tube, non-sterile Gastric calibration tube, non-sterile| Primary Device ID | 20884521517384 |
| NIH Device Record Key | dd159277-1d34-4750-8873-db010f0bf6d6 |
| Commercial Distribution Discontinuation | 2019-03-25 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | GastriSail |
| Version Model Number | GPS40 |
| Catalog Number | GPS40 |
| Company DUNS | 058614483 |
| Company Name | Covidien LP |
| 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 | false |
| 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 |
Customer Support Contacts
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com |
Device Dimensions
| Outer Diameter | 40 Millimeter |
| Outer Diameter | 40 Millimeter |
| Outer Diameter | 40 Millimeter |
| Outer Diameter | 40 Millimeter |
| Outer Diameter | 40 Millimeter |
| Outer Diameter | 40 Millimeter |
| Outer Diameter | 40 Millimeter |
| Outer Diameter | 40 Millimeter |
| Outer Diameter | 40 Millimeter |
| Outer Diameter | 40 Millimeter |
| Outer Diameter | 40 Millimeter |
| Outer Diameter | 40 Millimeter |
| Outer Diameter | 40 Millimeter |
| Outer Diameter | 40 Millimeter |
| Outer Diameter | 40 Millimeter |
| Outer Diameter | 40 Millimeter |
| Catheter Gauge | 40 French |
| Catheter Gauge | 40 French |
| Catheter Gauge | 40 French |
| Catheter Gauge | 40 French |
| Catheter Gauge | 40 French |
| Catheter Gauge | 40 French |
| Catheter Gauge | 40 French |
| Catheter Gauge | 40 French |
| Catheter Gauge | 40 French |
| Catheter Gauge | 40 French |
| Catheter Gauge | 40 French |
| Catheter Gauge | 40 French |
| Catheter Gauge | 40 French |
| Catheter Gauge | 40 French |
| Catheter Gauge | 40 French |
| Catheter Gauge | 40 French |
| Catheter Gauge | 40 French |
| Catheter Gauge | 40 French |
| Catheter Gauge | 40 French |
| Catheter Gauge | 40 French |
| Catheter Gauge | 40 French |
| Catheter Gauge | 40 French |
| Catheter Gauge | 40 French |
| Catheter Gauge | 40 French |
| Catheter Gauge | 40 French |
| Catheter Gauge | 40 French |
| Catheter Gauge | 40 French |
| Catheter Gauge | 40 French |
| Catheter Gauge | 40 French |
| Catheter Gauge | 40 French |
| Catheter Gauge | 40 French |
| Catheter Gauge | 40 French |
| Catheter Gauge | 40 French |
| Catheter Gauge | 40 French |
| Catheter Gauge | 40 French |
| Catheter Gauge | 40 French |
| Catheter Gauge | 40 French |
Operating and Storage Conditions
| Storage Environment Atmospheric Pressure | Between 500 KiloPascal and 1060 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 500 KiloPascal and 1060 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 500 KiloPascal and 1060 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 500 KiloPascal and 1060 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 500 KiloPascal and 1060 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 500 KiloPascal and 1060 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 500 KiloPascal and 1060 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 500 KiloPascal and 1060 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 500 KiloPascal and 1060 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 500 KiloPascal and 1060 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 500 KiloPascal and 1060 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 500 KiloPascal and 1060 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 500 KiloPascal and 1060 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 500 KiloPascal and 1060 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 500 KiloPascal and 1060 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 500 KiloPascal and 1060 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 500 KiloPascal and 1060 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 500 KiloPascal and 1060 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 500 KiloPascal and 1060 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 500 KiloPascal and 1060 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 500 KiloPascal and 1060 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 500 KiloPascal and 1060 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 500 KiloPascal and 1060 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 500 KiloPascal and 1060 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10884521517387 [Primary] |
| GS1 | 10884521661516 [Package] Package: PACK [3 Units] Discontinued: 2019-03-25 Not in Commercial Distribution |
| GS1 | 20884521517384 [Package] Contains: 10884521517387 Package: CASE [3 Units] Discontinued: 2019-03-25 Not in Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K160654
FDA Product Code
| KNT | TUBES, GASTROINTESTINAL (AND ACCESSORIES) |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2022-07-08 |
| Device Publish Date | 2016-10-17 |
Devices Manufactured by Covidien LP
| 10884521744134 - TruClear | 2024-04-23 Calibration Insert |
| 10884521744141 - TruClear | 2024-04-23 Calibration Insert |
| 10884521557048 - INVOS | 2024-04-22 Docking Station |
| 10884521833869 - Endoflip | 2024-04-22 Refurbished 300 Pump System With Pre-Use Tube |
| 20884521140216 - ClosureFast | 2024-04-15 Compression Bandages,Cohesive,6"" x 15' (15.24 cm x 4.572 m) |
| 10884521543430 - LiquiBand Exceed | 2024-04-15 2-Octyl Cyanoacrylate |
| 20884521140209 - ClosureFast | 2024-04-10 Compression Bandages,Cohesive,4"" x 15' (10.16 cm x 4.572 m) |
| 10884521539921 - VenaSeal | 2024-04-09 VenaSeal Closure System |
Trademark Results [GastriSail]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GASTRISAIL 86329365 4757520 Live/Registered |
Covidien LP 2014-07-07 |
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