| Primary Device ID | 00643169889668 |
| NIH Device Record Key | 7109a123-bc3f-4533-9ae9-5c2212ba8a2a |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 5492AL |
| Company DUNS | 136201675 |
| Company Name | MEDTRONIC, 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 | true |
| Serial Number | false |
| 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 |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00643169889668 [Primary] |
| DSA | CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR) |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00643169889668]
Moist Heat or Steam Sterilization;Hydrogen Peroxide
[00643169889668]
Moist Heat or Steam Sterilization;Hydrogen Peroxide
[00643169889668]
Moist Heat or Steam Sterilization;Hydrogen Peroxide
[00643169889668]
Moist Heat or Steam Sterilization;Hydrogen Peroxide
[00643169889668]
Moist Heat or Steam Sterilization;Hydrogen Peroxide
[00643169889668]
Moist Heat or Steam Sterilization;Hydrogen Peroxide
[00643169889668]
Moist Heat or Steam Sterilization;Hydrogen Peroxide
[00643169889668]
Moist Heat or Steam Sterilization;Hydrogen Peroxide
[00643169889668]
Moist Heat or Steam Sterilization;Hydrogen Peroxide
[00643169889668]
Moist Heat or Steam Sterilization;Hydrogen Peroxide
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-11-01 |
| Device Publish Date | 2021-10-24 |
| 00199150050161 - NA | 2025-09-29 CUSTOM PACK HLO BB12D44R4 PUMP PK |
| 00199150050178 - NA | 2025-09-29 CUSTOM PACK BB4W67R26 EVL ADULT E |
| 00199150050185 - NA | 2025-09-29 CUSTOM PACK BB4Q12R27 UNIV H/L |
| 20199150050202 - NA | 2025-09-29 CUSTOM PACK BB12P63R 4PK GPS TABLE PK |
| 00199150050871 - NA | 2025-09-29 CUSTOM PACK BB11R66R2 TBL 1/4 |
| 00763000877033 - SPRINTER® LEGEND | 2025-09-29 BALLOON SPL15006X SPR LEG RX US M |
| 00763000877040 - SPRINTER® LEGEND | 2025-09-29 BALLOON SPL15010X SPR LEG RX US M |
| 00763000877057 - SPRINTER® LEGEND | 2025-09-29 BALLOON SPL15012X SPR LEG RX US M |