FDA UDI
In Commercial Distribution
🇺🇸 United States
MyView™ Presence Tag
DI: 00843997008259
·
Model: 3715
·
MASIMO CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MyView™ Presence Tag
- Primary DI
- 00843997008259
- Version / Model
- 3715
- Company Name
- MASIMO CORPORATION
- Labeler DUNS
- 780421038
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- fef261ae-5f93-4893-b477-c432a37fa605
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MSX | SYSTEM,NETWORK AND COMMUNICATION,PHYSIOLOGICAL MONITORS | Cardiovascular | 870.2300 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37353 | Pulse oximetry telemetric monitoring system transmitter | A body-worn, battery-powered component of a pulse oximetry telemetric monitoring system designed to continuously measure and wirelessly transmit haemoglobin oxygen saturation (SpO2) signals to the system's receiver. The transmitter typically includes an antenna and attached sensors (e.g., lead wires and electrodes) that are connected to the patient. This is a reusable device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00843997008259 | GS1 |
Customer Contacts
- Phone
- +1(949)297-7498
- [email protected]