| Primary Device ID | 03615041990516 |
| NIH Device Record Key | 6947146b-b38d-4691-8013-ba743b6c6a01 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Capsule Surveillance |
| Version Model Number | Capsule Surveillance 2024-1 HF01 |
| Company DUNS | 001291111 |
| Company Name | Philips North America LLC |
| 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 | 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03615041990516 [Primary] |
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-01-16 |
| Device Publish Date | 2026-01-08 |
| 03615041990554 | Capsule Surveillance 2024-1 HF02 |
| 03615041990547 | Capsule Surveillance 2024-1 PU01 |
| 03615041990516 | Capsule Surveillance 2024-1 HF01 |
| 03615041990509 | Capsule Surveillance 2023-1 PU01 HF01 |
| 03615041990486 | Capsule Surveillance 2024-1 |
| 03615041990479 | Capsule Surveillance 2023-1 PU02 |
| 03615041990455 | Capsule Surveillance 2023-1 PU01 |
| 03615041990431 | Capsule Surveillance 2023-1 |
| 03615041990394 | Capsule Surveillance 2022-1 PU01 |
| 03615041990363 | Capsule Surveillance 2022-1 |