Endoflip
GUDID 10884521833869
Refurbished 300 Pump System With Pre-Use Tube
Covidien LP
Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system| Primary Device ID | 10884521833869 |
| NIH Device Record Key | fdc647bf-d36a-47b9-b32e-561c27bb81b4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Endoflip |
| Version Model Number | EF-301-RFB |
| 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 | false |
| Lot Batch | false |
| Serial Number | true |
| 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 |
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 |
Operating and Storage Conditions
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile, Keep dry, This side up |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile, Keep dry, This side up |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile, Keep dry, This side up |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile, Keep dry, This side up |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile, Keep dry, This side up |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile, Keep dry, This side up |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile, Keep dry, This side up |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile, Keep dry, This side up |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile, Keep dry, This side up |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile, Keep dry, This side up |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile, Keep dry, This side up |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile, Keep dry, This side up |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile, Keep dry, This side up |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile, Keep dry, This side up |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile, Keep dry, This side up |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile, Keep dry, This side up |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile, Keep dry, This side up |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile, Keep dry, This side up |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10884521833869 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K231861
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 | 2024-04-22 |
| Device Publish Date | 2024-04-12 |
On-Brand Devices [Endoflip]
| 20884521809427 | ENDO CATHETER EF-325N 8CM NASAL TIP |
| 20884521809410 | ENDO CATHETER EF-322N 16CM NASAL TIP |
| 10884521809376 | LK-103 ENDOFLIP LOCALIZATION KIT US |
| 10884521809321 | PRE USE CHECK KIT LK-200 FLIP |
| 10884521809314 | TOPOGRAPHY SYSTEM DD-961 |
| 10884521809307 | ENDOFLIP 1 SYSTEM EF-100 |
| 10884521808096 | Endoflip system 1.0 refurbished |
| 10884521826823 | 300 Cart |
| 10884521827691 | Pre-Use Tube |
| 10884521826830 | 300 Reader |
| 10884521826816 | 300 Display System With Reader |
| 10884521826809 | 300 Pump System With Pre-Use Tube |
| 10884521833869 | Refurbished 300 Pump System With Pre-Use Tube |
Trademark Results [Endoflip]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ENDOFLIP 77172827 4116590 Live/Registered |
FLIP TECHNOLOGIES LIMITED 2007-05-04 |
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