| Primary Device ID | 10884521082601 | 
| NIH Device Record Key | 7800a0ae-e3ee-4876-a409-307fc51355bd | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Kendall SCD | 
| Version Model Number | 95255 | 
| Catalog Number | 95255 | 
| 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 | false | 
| 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 | 
| 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 | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT | 
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT | 
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT | 
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT | 
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT | 
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT | 
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT | 
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT | 
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT | 
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT | 
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT | 
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT | 
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT | 
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT | 
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT | 
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT | 
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT | 
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT | 
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT | 
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT | 
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT | 
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT | 
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT | 
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT | 
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT | 
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT | 
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT | 
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT | 
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT | 
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT | 
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT | 
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT | 
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT | 
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT | 
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT | 
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT | 
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT | 
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT | 
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT | 
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT | 
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT | 
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT | 
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT | 
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT | 
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 10884521082601 [Primary] | 
| JOW | SLEEVE, LIMB, COMPRESSIBLE | 
| Steralize Prior To Use | false | 
| Device Is Sterile | false | 
| Public Version Status | Update | 
| Device Record Status | Published | 
| Public Version Number | 8 | 
| Public Version Date | 2019-11-04 | 
| Device Publish Date | 2017-03-21 | 
| 10884521856127 - Vital Sync | 2025-09-09 VITAL SYNC V3 SOFTWARE | 
| 10884521856134 - Vital Sync | 2025-08-26 VITAL SYNC V4 SOFTWARE | 
| 20884521854144 - DAR | 2025-08-18 L Connector Double Swivel | 
| 10884521825666 - McGRATH | 2025-08-11 Rechargeable Battery;For McGRATH (TM) MAC Video Laryngoscope | 
| 20884521855370 - Valleylab SM | 2025-07-18 Smoke Management Pencil Adapter | 
| 10884521845985 - INVOS | 2025-07-11 INVOS(TM) rSO2 micro-module;For use with GE HealthCare Patient Monitors | 
| 20884521829005 - DAR | 2025-07-04 Adult Electrostatic Filter HME Large | 
| 20884521829104 - DAR | 2025-07-04 Pediatric Electrostatic Filter HME Small | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  KENDALL SCD  85538414  4240975 Live/Registered | KPR U.S., LLC 2012-02-09 |