Primary Device ID | 00843997001540 |
NIH Device Record Key | b7b42b4e-452c-4b11-a4d3-e5e9ec474ac2 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | MasimoSET® Accessory Ear Clip |
Version Model Number | 1606 |
Company DUNS | 780421038 |
Company Name | MASIMO CORPORATION |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
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 |
Phone | +1(949)297-7498 |
TechService-US@masimo.com | |
Phone | +1(949)297-7498 |
TechService-US@masimo.com | |
Phone | +1(949)297-7498 |
TechService-US@masimo.com | |
Phone | +1(949)297-7498 |
TechService-US@masimo.com | |
Phone | +1(949)297-7498 |
TechService-US@masimo.com | |
Phone | +1(949)297-7498 |
TechService-US@masimo.com | |
Phone | +1(949)297-7498 |
TechService-US@masimo.com | |
Phone | +1(949)297-7498 |
TechService-US@masimo.com | |
Phone | +1(949)297-7498 |
TechService-US@masimo.com | |
Phone | +1(949)297-7498 |
TechService-US@masimo.com | |
Phone | +1(949)297-7498 |
TechService-US@masimo.com | |
Phone | +1(949)297-7498 |
TechService-US@masimo.com | |
Phone | +1(949)297-7498 |
TechService-US@masimo.com | |
Phone | +1(949)297-7498 |
TechService-US@masimo.com | |
Phone | +1(949)297-7498 |
TechService-US@masimo.com | |
Phone | +1(949)297-7498 |
TechService-US@masimo.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00843997001540 [Primary] |
DPZ | Oximeter, ear |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2018-03-29 |
Device Publish Date | 2016-09-24 |
00843997017640 - Stork | 2024-11-08 Stork Hub |
00843997017589 - Stork | 2024-11-08 Stork Sensor |
00843997016551 - Home Health Kit | 2024-09-17 Home Health Kit |
00843997017442 - Radius PPG | 2024-09-17 Masimo SafetyNet, Radius PPG Chip |
00843997009065 - Radius VSM | 2024-08-27 Radius VSM Multi-functional Reusable Pod, 1/Box |
00843997009430 - Radius VSM | 2024-08-27 Radius VSM NIBP Module, 1/Box |
00843997010337 - Radius VSM | 2024-08-27 Radius VSM Kit with Reusable Pod & NIBP |
00843997009263 - Radius VSM | 2024-08-27 Radius VSM Kit with NIBP |