Primary Device ID | 00884838124233 |
NIH Device Record Key | 6b471d92-a672-4d4b-af3a-cacfa42145ea |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | TOMTEC ARENA |
Version Model Number | TTA2.53 |
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 | true |
Serial Number | false |
Manufacturing Date | true |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | true |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00884838124233 [Primary] |
QIH | Automated Radiological Image Processing Software |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-07-11 |
Device Publish Date | 2024-07-03 |
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00884838123670 - Ultrasound System 5300P | 2025-07-28 As part of SW 2.0 |
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