CARDIOVIT® AT-1 3.910950
GUDID 07613365000009
The CARDIOVIT® AT-1 is a 12-lead ECG device used for the recording, analysis and evaluation of ECG recordings.
Schiller AG
Electrocardiograph, professional, multichannel| Primary Device ID | 07613365000009 |
| NIH Device Record Key | 95d3a08d-7b5b-439b-a3c3-dccbf24fad5a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CARDIOVIT® AT-1 |
| Version Model Number | 3.910950 |
| Catalog Number | 3.910950 |
| Company DUNS | 480868538 |
| Company Name | Schiller AG |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| 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 | +41417664242 |
| info@schiller.ch | |
| Phone | +41417664242 |
| info@schiller.ch | |
| Phone | +41417664242 |
| info@schiller.ch | |
| Phone | +41417664242 |
| info@schiller.ch | |
| Phone | +41417664242 |
| info@schiller.ch | |
| Phone | +41417664242 |
| info@schiller.ch | |
| Phone | +41417664242 |
| info@schiller.ch | |
| Phone | +41417664242 |
| info@schiller.ch | |
| Phone | +41417664242 |
| info@schiller.ch | |
| Phone | +41417664242 |
| info@schiller.ch | |
| Phone | +41417664242 |
| info@schiller.ch | |
| Phone | +41417664242 |
| info@schiller.ch | |
| Phone | +41417664242 |
| info@schiller.ch | |
| Phone | +41417664242 |
| info@schiller.ch | |
| Phone | +41417664242 |
| info@schiller.ch | |
| Phone | +41417664242 |
| info@schiller.ch | |
| Phone | +41417664242 |
| info@schiller.ch | |
| Phone | +41417664242 |
| info@schiller.ch | |
| Phone | +41417664242 |
| info@schiller.ch | |
| Phone | +41417664242 |
| info@schiller.ch | |
| Phone | +41417664242 |
| info@schiller.ch | |
| Phone | +41417664242 |
| info@schiller.ch | |
| Phone | +41417664242 |
| info@schiller.ch | |
| Phone | +41417664242 |
| info@schiller.ch | |
| Phone | +41417664242 |
| info@schiller.ch | |
| Phone | +41417664242 |
| info@schiller.ch | |
| Phone | +41417664242 |
| info@schiller.ch | |
| Phone | +41417664242 |
| info@schiller.ch |
Operating and Storage Conditions
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07613365000009 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K946205
FDA Product Code
| DPS | 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 | 4 |
| Public Version Date | 2020-02-17 |
| Device Publish Date | 2016-09-18 |
Devices Manufactured by Schiller AG
| 07613365002201 - Schiller ECG D-SUB C 3.5 x10 IEC | 2023-10-17 10-wire patient cable IEC, clip-type, 3.5m |
| 07613365002232 - Schiller ECG D-SUB B 2.0 x10 IEC | 2023-10-17 10-wire patient cable IEC, banana plug, 2m |
| 07613365002775 - CARDIOVIT AT-180 | 2023-10-17 The CARDIOVIT AT-180 is an electrocardiograph intended to be used by trained operators under the direct supervision of a license |
| 07613365003291 - Schiller ECG EL-LT B 1.3/0.78 x4 IEC | 2023-10-17 Detachable single wires banana plug, Balanced Set 4 pcs (C3r, C4r, C8, C9) for patient cable 2.400142, 2.400141 |
| 07613365003802 - Schiller ECG EL-LT C 1.3/0.78 x4 IEC | 2023-10-17 Detachable single wires clip type, Balanced Set 4 pcs (C3r, C4r, C8, C9) for patient cable 2.400140, 2.400139 |
| 07613365002072 - Schiller IBP transducer connecting cable | 2023-10-05 IBP LP 3.0 PVB CC |
| 07613365003093 - Schiller IBP transducer connecting cable | 2023-10-05 IBP LP 3.7 OHMEDA CC |
| 07613365003499 - Schiller IBP transducer connecting cable | 2023-10-05 IBP LP 4.5 Transpac IV CC |
Trademark Results [CARDIOVIT]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CARDIOVIT 76508787 2855699 Live/Registered |
Schiller Holding AG 2003-04-23 |
 CARDIOVIT 73810989 1596212 Dead/Cancelled |
SCHILLER AMERICA, INC. 1989-07-06 |
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