BabyMAC 402207-810
GUDID 20885403252218
Infant/Pediatric Resting ECG Electrodes for 12-lead
Carefusion Finland 320 Oy
Neonatal electrocardiographic electrode| Primary Device ID | 20885403252218 |
| NIH Device Record Key | 9a4c1444-a503-454f-92b3-1e1f3a125d01 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BabyMAC |
| Version Model Number | 402207-810 |
| Catalog Number | 402207-810 |
| Company DUNS | 367919120 |
| Company Name | Carefusion Finland 320 Oy |
| Device Count | 50 |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| 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
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10885403252211 [Unit of Use] |
| GS1 | 20885403252218 [Package] Contains: 70885403252213 Package: Box [10 Units] In Commercial Distribution |
| GS1 | 70885403252213 [Primary] |
FDA Product Code
| DRX | Electrode, electrocardiograph |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-09-14 |
Devices Manufactured by Carefusion Finland 320 Oy
| 10190752100015 - Multi-Link™ | 2024-05-27 Multi-Link™ X2 ECG Reusable Telemetry Adapter, 5/6-Lead for Philips IntelliVue |
| 10190752100022 - Multi-Link™ | 2024-05-27 Multi-Link™ X2 ECG Reusable Telemetry Adapter, 5-Lead for Mindray |
| 10190752100046 - Multi-Link™ | 2024-05-27 Multi-Link™ X2 ECG Reusable Telemetry Adapter, 3-Lead for Nihon Kohden |
| 10190752100084 - Multi-Link™ | 2024-05-27 Multi-Link™ X2 Single-Patient-Use Direct-Connect Telemetry ECG Leadwire Set, 3-Lead Set for Philips, Grabber, AHA |
| 10190752100107 - Multi-Link™ | 2024-05-27 Multi-Link™ X2 Single-Patient-Use Direct-Connect Telemetry ECG Leadwire Set, 5-Lead Set for Philips, Grabber, AHA |
| 10190752100121 - Multi-Link™ | 2024-05-27 Multi-Link™ X2 Single-Patient-Use Direct-Connect Telemetry ECG Leadwire Set, 6-Lead Set for Philips, Grabber, AHA |
| 10190752100145 - Multi-Link™ | 2024-05-27 Multi-Link™ X2 Single-Patient-Use Direct-Connect Telemetry ECG Leadwire Set, 3-Lead Set for Philips, Snap, AHA |
| 10190752100169 - Multi-Link™ | 2024-05-27 Multi-Link™ X2 Single-Patient-Use Direct-Connect Telemetry ECG Leadwire Set, 5-Lead Set for Philips, Snap, AHA |
Trademark Results [BabyMAC]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BABYMAC 86712699 not registered Dead/Abandoned |
FIRST ONE AUSTRALIA PTY LTD 2015-08-03 |
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