FDA UDI
In Commercial Distribution
🇺🇸 United States
INVOS
DI: 10884521845039
·
Model: PMC71V-SF
·
Covidien LP
Product Codes
1
GMDN Terms
2
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- INVOS
- Primary DI
- 10884521845039
- Version / Model
- PMC71V-SF
- Company Name
- Covidien LP
- Labeler DUNS
- 058614483
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-02-08
- Public Version
- 3
- Public Version Date
- 2025-06-24
- Public Version Status
- Update
- Public Device Record Key
- f3a0c1d5-c556-4468-9dd1-393b597a72da
Device Description
rSO2 Preamplifier
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
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| MUD | Oximeter, tissue saturation | Cardiovascular | 870.2700 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 17942 | Cerebral oximeter | A mains electricity (AC-powered) photoelectric device that noninvasively measures the brain tissue blood oxygen saturation and venous oxygen saturation in the brain. It is typically used as an adjunct monitor for the regional haemoglobin oxygen saturation of blood in the brain of a paediatric or adult patient. It uses a cerebral sensor(s) having a light source and photodiode detector that is/are placed on the scalp/head. Position-1 detector detects infrared light absorption of extracranial blood and position-2 detector detects infrared light absorption of cerebral blood. Cerebral oxygenation is calculated by subtracting the absorption measured at site 1 from that measured at site 2. | No | Active |
| 46615 | Tissue saturation oximeter | A mains electricity (AC-powered) photoelectric device that noninvasively calculates the percent oxygen saturation of haemoglobin in a volume of tissue (StO2) to assess the amount of oxygen delivered to that tissue, typically during circulatory or perfusion examinations of skeletal muscle or when there is a suspicion of compromised circulation. The device typically includes a monitor for data analysis and display, a light-transmitting cable, and a tissue-surface sensor. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20884521845036 | GS1 | CASE | 12 | In Commercial Distribution | |
| Primary | 10884521845039 | GS1 |
Customer Contacts
- Phone
- +1(508)261-8000
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K211561 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Fragile, Keep dry
- Type
- Handling Environment Humidity
- Temperature Range
- 15 – 95 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -40 – 158 Degrees Fahrenheit
- Type
- Storage Environment Humidity
- Temperature Range
- 5 – 95 Percent (%) Relative Humidity
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 47 – 108 KiloPascal
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 62 – 108 KiloPascal
- Type
- Handling Environment Temperature
- Temperature Range
- 50 – 95 Degrees Fahrenheit