Primary Device ID | 00884838108592 |
NIH Device Record Key | 946d9d83-5514-49f3-bc66-62654288a417 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Transducer mL26-8 |
Version Model Number | 989606722361 |
Company DUNS | 063377717 |
Company Name | Philips Ultrasound 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 | false |
Serial Number | true |
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 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00884838108592 [Primary] |
IYN | System, Imaging, Pulsed Doppler, Ultrasonic |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2025-02-24 |
Device Publish Date | 2023-05-22 |
00884838123625 - Ultrasound System 5500CV | 2025-07-28 As part of SW 2.0 |
00884838123632 - Ultrasound System 5500P | 2025-07-28 Part of SW 2.0 |
00884838123649 - Ultrasound System 5500W | 2025-07-28 Part of SW 2.0 |
00884838123656 - Ultrasound System 5300G | 2025-07-28 Part of SW 2.0 |
00884838123663 - Ultrasound System 5300W | 2025-07-28 As part of SW 2.0 |
00884838123670 - Ultrasound System 5300P | 2025-07-28 As part of SW 2.0 |
00884838123687 - Ultrasound System 5500G | 2025-07-28 As part of SW 2.0 |
00884838125964 - Lumify USB-C to USB-C Transducer cable | 2025-07-22 Lumify USB-C to USB-C Transducer cable |