ManoScan
GUDID 10884521853317
Manoscan Cart
Given Imaging, Inc.
Manometric gastrointestinal motility analysis system| Primary Device ID | 10884521853317 |
| NIH Device Record Key | 68db0a7e-60fc-474f-911f-d5f1876ca226 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ManoScan |
| Version Model Number | FGS-8038 |
| Company DUNS | 090073722 |
| Company Name | Given Imaging, 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 | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| 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 |
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 |
Device Dimensions
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Fragile, Keep dry |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile, Keep dry |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile, Keep dry |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile, Keep dry |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile, Keep dry |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile, Keep dry |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile, Keep dry |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile, Keep dry |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile, Keep dry |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile, Keep dry |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile, Keep dry |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile, Keep dry |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile, Keep dry |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile, Keep dry |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile, Keep dry |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile, Keep dry |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10884521853317 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K151086
FDA Product Code
| FFX | SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL) |
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 | 2025-02-03 |
| Device Publish Date | 2025-01-25 |
On-Brand Devices [ManoScan]
| 07290101365709 | accessory kit |
| 07290101363699 | A400 accessory kit |
| 07290101363347 | A510 Module |
| 04260167482989 | ESO Catheter, RFG |
| 04260167482569 | ESO Catheter |
| 04260167482552 | AR Catheter, Regular |
| 04260167482521 | ESO Catheter, SD Small |
| 04260167482514 | ESO Catheter, SD Regular |
| 04260167482484 | ESO Catheter |
| 04260167482477 | AR Catheter, Regular |
| 04260167482460 | AR Catheter, Small |
| 04260167482453 | ESO Catheter, SD Small |
| 04260167482446 | ESO Z Catheter |
| 04260167482439 | ESO With Extended Tip |
| 04260167482422 | ESO 3D Catheter |
| 04260167480961 | ESO Catheter, SD Regular |
| 04260167480954 | AR 3D Probe |
| 10884521853317 | Manoscan Cart |
Trademark Results [ManoScan]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MANOSCAN 85684466 4301322 Live/Registered |
COVIDIEN LP 2012-07-23 |
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