FDA UDI
In Commercial Distribution
🇺🇸 United States
MR Patient Care SpO2 Grip Starter Kit (20 piece)
DI: 00884838128408
·
Model: SpO2 Grip Starter Kit (20 piece)
·
Philips Medizin Systeme Böblingen GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- MR Patient Care SpO2 Grip Starter Kit (20 piece)
- Primary DI
- 00884838128408
- Version / Model
- SpO2 Grip Starter Kit (20 piece)
- Catalog Number
- 989803167111
- Company Name
- Philips Medizin Systeme Böblingen GmbH
- Labeler DUNS
- 314101143
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-05-20
- Public Version
- 1
- Public Version Date
- 2025-05-28
- Public Version Status
- New
- Public Device Record Key
- 9159875c-9223-449b-8890-233eeca438b1
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
- Yes
- 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 |
|---|---|---|---|---|
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | Cardiovascular | 870.2300 | 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 | 00884838128408 | GS1 |
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
- 429 – 765 Millimeter of Mercury
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 570 – 1020 millibar
- Type
- Storage Environment Humidity
- Temperature Range
- 5 – 80 Percent (%) Relative Humidity
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 57 – 102 KiloPascal