MR Patient Care SpO2 Grip Starter Kit (20 piece)

Basic Information

• Brand Name: MR Patient Care SpO2 Grip Starter Kit (20 piece)
• Primary DI: 10884838101026
• Version / Model: SpO2 Grip Starter Kit (20 piece)
• Catalog Number: 989803167111
• Company Name: Philips Ds North America LLC
• Labeler DUNS: 013649151
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-05-03
• Public Version: 5
• Public Version Date: 2024-02-01
• Public Version Status: Update
• Public Device Record Key: c7bd8314-67ec-4431-bd41-d9f505e936bd

Device Description

Starter pack for the Quick Connect SpO2 Sensor (989803161991) that includes 5 each of Adult, Pediatric, Infant and Neonatal disposable grips.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Conditional
• 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
DQA	Oximeter	Cardiovascular	870.2700	2

GMDN Terms

Code	Name	Definition	Implantable	Status
31658	Pulse oximeter probe, single-use	A photoelectric device designed to be applied externally to a body site (e.g., fingertip, ear lobe, bridge of nose, toe, or bridge of the foot) for the transcutaneous measurement of haemoglobin oxygen saturation (SpO2) in arterial blood using signals produced by a light-emitting diode (LED) and received by a photodetector. The signals are subsequently transmitted to an oximeter/monitor (not included) which measures and displays the SpO2. The is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10884838101026	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -20 – 60 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: -4 – 140 Degrees Fahrenheit
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 570 – 1020 millibar
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 57 – 102 KiloPascal
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 429 – 765 Millimeter of Mercury
• Type: Storage Environment Humidity
• Temperature Range: 5 – 80 Percent (%) Relative Humidity