BEUDAMED

FDA UDI Not in Commercial Distribution 🇺🇸 United States

Opioid Halo

DI: 00843997016100 · Model: 4725 · MASIMO CORPORATION

View on AccessGUDID

Product Codes

1

GMDN Terms

1

Identifiers

1

Pkg Device Count

1

Let the assistant research this device

The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.

Free to try · every answer cites its records

Ask the Research Assistant See examples

Basic Information

Brand Name: Opioid Halo
Primary DI: 00843997016100
Version / Model: 4725
Catalog Number: 4725
Company Name: MASIMO CORPORATION
Labeler DUNS: 780421038
Distribution Status: Not in Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2024-07-10
Public Version: 2
Public Version Date: 2025-01-14
Public Version Status: Update
Public Device Record Key: f2d0cfff-d340-402e-9c46-099ce6ed5b92
Distribution End Date: 2024-12-31

Device Description

Opioid Halo - Replacement Sensor

Device Characteristics

Single Use: Yes
Prescription Use (Rx): No
Over the Counter (OTC): Yes
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: No
Has Serial Number: No
Has Lot/Batch Number: Yes
Has Manufacturing Date: No
Has Expiration Date: Yes
Has Donation ID: No

Sterilization

Is Sterile: No
Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QVT	Monitor For Opioid Induced Impairment Of Oxygenation	Anesthesiology	868.2250	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47581	Pulse Co-oximeter probe, single-use	A photoelectric component of a pulse Co-oximeter that is applied externally to a body part (e.g., a fingertip for adults, the hand or foot for neonates), for the transcutaneous multiwave measurement of carboxy-haemoglobin saturation (SpCO) and typically several other related parameters such as haemoglobin oxygen saturation (SpO2), methaemoglobin saturation (SpMet), haemoglobin concentration (SpHb), haematocrit, and pulse rate using light detection. Signals from the probe, produced by a light-emitting diode (LED) and a receiving detector, are used to calculate results which are digitally displayed on the Co-oximeter's computerized unit. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00843997016100	GS1

Customer Contacts

Phone: +1(949)297-7498
Email: [email protected]

Storage Conditions

Type: Handling Environment Temperature
Temperature Range: 0 – 40 Degrees Celsius
Type: Storage Environment Humidity
Temperature Range: 5 – 95 Percent (%) Relative Humidity
Type: Handling Environment Humidity
Temperature Range: 5 – 95 Percent (%) Relative Humidity
Type: Storage Environment Temperature
Temperature Range: 0 – 50 Degrees Celsius