SafetyNet
GUDID 00843997010436
MASIMO CORPORATION
Multiple-patient intensive/general healthcare physiologic monitoring system| Primary Device ID | 00843997010436 |
| NIH Device Record Key | fccbbff5-6462-4981-8a01-74a39610154f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SafetyNet |
| Version Model Number | 9095 |
| Company DUNS | 780421038 |
| Company Name | MASIMO CORPORATION |
| 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 | false |
| 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 |
Customer Support Contacts
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00843997010436 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K071047
FDA Product Code
| MSX | SYSTEM,NETWORK AND COMMUNICATION,PHYSIOLOGICAL MONITORS |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2020-02-06 |
| Device Publish Date | 2016-09-21 |
Devices Manufactured by MASIMO CORPORATION
Trademark Results [SafetyNet]
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