RF Assure
GUDID 10884521705265
RF Assure Detection System Console Model 200 Refurbished
Covidien LP
Surgical sponge-counting rack| Primary Device ID | 10884521705265 |
| NIH Device Record Key | d3394376-430f-45e0-8ef6-10700d4addce |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | RF Assure |
| Version Model Number | 01-0027R |
| Company DUNS | 058614483 |
| Company Name | Covidien LP |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | true |
| 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 |
Device Dimensions
| Height | 4.5 Inch |
| Width | 9.75 Inch |
| Weight | 7 Pound |
| Length | 11.75 Inch |
| Height | 4.5 Inch |
| Width | 9.75 Inch |
| Weight | 7 Pound |
| Length | 11.75 Inch |
| Height | 4.5 Inch |
| Width | 9.75 Inch |
| Weight | 7 Pound |
| Length | 11.75 Inch |
| Height | 4.5 Inch |
| Width | 9.75 Inch |
| Weight | 7 Pound |
| Length | 11.75 Inch |
| Height | 4.5 Inch |
| Width | 9.75 Inch |
| Weight | 7 Pound |
| Length | 11.75 Inch |
| Height | 4.5 Inch |
| Width | 9.75 Inch |
| Weight | 7 Pound |
| Length | 11.75 Inch |
| Height | 4.5 Inch |
| Width | 9.75 Inch |
| Weight | 7 Pound |
| Length | 11.75 Inch |
| Height | 4.5 Inch |
| Width | 9.75 Inch |
| Weight | 7 Pound |
| Length | 11.75 Inch |
| Height | 4.5 Inch |
| Width | 9.75 Inch |
| Weight | 7 Pound |
| Length | 11.75 Inch |
| Height | 4.5 Inch |
| Width | 9.75 Inch |
| Weight | 7 Pound |
| Length | 11.75 Inch |
| Height | 4.5 Inch |
| Width | 9.75 Inch |
| Weight | 7 Pound |
| Length | 11.75 Inch |
| Height | 4.5 Inch |
| Width | 9.75 Inch |
| Weight | 7 Pound |
| Length | 11.75 Inch |
| Height | 4.5 Inch |
| Width | 9.75 Inch |
| Weight | 7 Pound |
| Length | 11.75 Inch |
Operating and Storage Conditions
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10884521705265 [Primary] |
FDA Product Code
| LWH | Counter, sponge, surgical |
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 | 2025-04-08 |
| Device Publish Date | 2025-03-31 |
Devices Manufactured by Covidien LP
| 10884521851566 - Valleylab | 2025-05-20 FT10 Electrosurgical Generator |
| 20884521850115 - McGRATH MAC | 2025-05-05 Disposable Laryngoscope Blade 3 |
| 20884521850122 - McGRATH MAC | 2025-05-05 Disposable Laryngoscope Blade 4 |
| 20884521850139 - McGRATH MAC | 2025-05-05 Disposable Laryngoscope Blade 2 |
| 30884521850143 - McGRATH MAC | 2025-05-05 Disposable Laryngoscope Blade 1 |
| 10884521851559 - Vital Sync | 2025-05-05 VITAL SYNC Mobile V4 SOFTWARE |
| 20884521084992 - DAR | 2025-04-21 Catheter Mount |
| 20884521842530 - DAR | 2025-04-21 Catheter Mount Extension Tube |
Trademark Results [RF Assure]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 RF ASSURE 85137002 4115790 Dead/Cancelled |
COVIDIEN LP 2010-09-23 |
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