Kestra Provided Device Patient Application
- Primary DI
- 00840241600412
- Brand
- Kestra Provided Device Patient Application
- Company
- Kestra Medical Technologies, Inc.
- Model
- 80740-010
- Catalog number
- 80740-010
- Device description
- ASSURE Patient Application for the Kestra Provided Device.
- Published
- 2026-02-04
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- false
Product Codes
| Code | Name |
|---|
| OUG | Medical Device Data System |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| OUG | Medical Device Data System | General Hospital | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00840241600399 | Previous | GS1 | 0 | |
| 00840241600412 | Primary | GS1 | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Medical equipment clinical data interfacing software | An application software designed for transportation, calculation, aggregation and derivation of data between patient connected medical devices and external information systems used in clinical settings for automating data collection and clinical information management. It is intended to transfer waveform, infusion data, laboratory data from medical devices/lab equipment into an electronic medical record (EMR) or an application for viewing and verification by a clinician. The data can be aggregated for, e.g., patient treatment summary calculations, ordering of infusion solutions/drugs, and laboratory sample tests; it is not primarily intended to manage diagnostic/patient images. |
Regulatory Flags
- DUNS number
- 060944361
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|
| 00840241600399 | Kestra Provided Device Patient Application | 80740-005 | 80740-005 | 2025-04-30 |
| 00840241600313 | ASSURE Wearable ECG | 80553-001 | 80553-001 | 2024-09-18 |
| 00840241600320 | Battery | 80499-003 | 80499-003 | 2024-09-18 |
| 00840241600337 | System Cable | 80500-003 | 80500-003 | 2024-09-18 |
| 00840241600344 | ASSURE Assist Service | 80739-001 | 80739-001 | 2024-09-18 |
| 00840241600382 | Kestra Provided Device Patient Application | 80740-001 | 80740-001 | 2024-09-18 |
| 00840241600238 | ASSURE WCD System | 80014-002 | 80014-002 | 2023-06-26 |
| 00840241600283 | ASSURE Patient Application | 80601-001 | 80601-001 | 2023-03-13 |
| 00840241600306 | CareStation Server | 80605-004 | 80605-004 | 2023-03-12 |
| 00840241600276 | CareStation Server | 80433-003 | 80433-003 | 2023-02-10 |
| 00840241600290 | CareStation Server | 80605-003 | 80605-003 | 2023-02-12 |
| 00840241600252 | ASSURE Patient Application | 80429-003 | 80429-003 | 2022-06-24 |
| 00840241600269 | CareStation Server | 80433-002 | 80433-002 | 2022-06-10 |
| 00840241600009 | ASSURE, Battery | 3322882-005 | 3322882-005 | 2021-11-15 |
| 00840241600016 | ASSURE, Charger | 3326633-004 | 3326633-004 | 2021-11-15 |
| 00840241600023 | ASSURE, Therapy Cable | 80004-003 | 80004-003 | 2021-11-15 |
| 00840241600030 | ASSURE, Monitor | 80008-003 | 80008-003 | 2021-11-15 |
| 00840241600047 | ASSURE WCD System | 80014-001 | 80014-001 | 2021-11-15 |
| 00840241600054 | ASSURE, Garment, Style A, Size 1 | 80015-001 | 80015-001 | 2021-11-15 |
| 00840241600061 | ASSURE, Garment, Style A, Size 2 | 80015-002 | 80015-002 | 2021-11-15 |
Other Devices Sharing Product Codes