Endolumik
GUDID G461EGCT40M1
40F Endolumik Gastric Calibration Tube, M Series
Endolumik, Inc.
Gastric calibration tube| Primary Device ID | G461EGCT40M1 |
| NIH Device Record Key | de6c6570-5b6e-40ba-a5e7-20f170394902 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Endolumik |
| Version Model Number | EGCT40M |
| Company DUNS | 117601339 |
| Company Name | Endolumik, Inc. |
| 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Device Dimensions
| Outer Diameter | 13.3 Millimeter |
| Outer Diameter | 13.3 Millimeter |
| Outer Diameter | 13.3 Millimeter |
| Outer Diameter | 13.3 Millimeter |
| Outer Diameter | 13.3 Millimeter |
| Outer Diameter | 13.3 Millimeter |
| Outer Diameter | 13.3 Millimeter |
| Outer Diameter | 13.3 Millimeter |
| Outer Diameter | 13.3 Millimeter |
| Outer Diameter | 13.3 Millimeter |
| Outer Diameter | 13.3 Millimeter |
| Outer Diameter | 13.3 Millimeter |
| Outer Diameter | 13.3 Millimeter |
| Outer Diameter | 13.3 Millimeter |
| Outer Diameter | 13.3 Millimeter |
Operating and Storage Conditions
| Handling Environment Atmospheric Pressure | Between 500 KiloPascal and 1060 KiloPascal |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 500 KiloPascal and 1060 KiloPascal |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 500 KiloPascal and 1060 KiloPascal |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 500 KiloPascal and 1060 KiloPascal |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 500 KiloPascal and 1060 KiloPascal |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 500 KiloPascal and 1060 KiloPascal |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 500 KiloPascal and 1060 KiloPascal |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 500 KiloPascal and 1060 KiloPascal |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 500 KiloPascal and 1060 KiloPascal |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 500 KiloPascal and 1060 KiloPascal |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 500 KiloPascal and 1060 KiloPascal |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 500 KiloPascal and 1060 KiloPascal |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 500 KiloPascal and 1060 KiloPascal |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 500 KiloPascal and 1060 KiloPascal |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 500 KiloPascal and 1060 KiloPascal |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | G461EGCT40M0 [Primary] |
| HIBCC | G461EGCT40M1 [Package] Contains: G461EGCT40M0 Package: [5 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K240069
FDA Product Code
| KNT | Tubes, Gastrointestinal (And Accessories) |
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 | 2024-08-14 |
| Device Publish Date | 2024-08-06 |
On-Brand Devices [Endolumik]
| G461EGCT400 | Endolumik Gastric Calibration Tube, 40F |
| G461EGCT361 | Endolumik Gastric Calibration Tube 36F |
| G461EGCT40M1 | 40F Endolumik Gastric Calibration Tube, M Series |
| G461EGCT36M1 | 36F Endolumik Gastric Calibration Tube, M Series |
Trademark Results [Endolumik]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ENDOLUMIK 98206606 not registered Live/Pending |
Endolumik, Inc. 2023-10-02 |
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