FDA UDI
In Commercial Distribution
🇺🇸 United States
MasimoSET® rainbow RAS-125c adult/pediatric acoustic respiration cloth sensor
DI: 10843997007068
·
Model: 3475
·
MASIMO CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
Basic Information
- Brand Name
- MasimoSET® rainbow RAS-125c adult/pediatric acoustic respiration cloth sensor
- Primary DI
- 10843997007068
- Version / Model
- 3475
- Catalog Number
- 3475
- Company Name
- MASIMO CORPORATION
- Labeler DUNS
- 780421038
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2016-08-24
- Public Version
- 6
- Public Version Date
- 2023-06-06
- Public Version Status
- Update
- Public Device Record Key
- 7e2686ae-4f52-40ff-a6c7-8e2d2c19b0dc
Device Description
MasimoSET® rainbow RAS-125c adult/pediatric acoustic respiration cloth sensor
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
- 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 |
|---|---|---|---|---|
| DQA | Oximeter | Cardiovascular | 870.2700 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 13754 | Electronic stethoscope | An external electronic listening device designed to detect and amplify extremely weak body sounds that may be difficult to perceive when using a mechanical stethoscope. This device may differentiate between sound tones and accentuate one (e.g., blood flow through a defective heart valve) over another. It is typically designed to be connected to a computing device, which may operate interpretive software sometimes provided with the stethoscope, for recording and/or display. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10843997007068 | GS1 | ||||
| Unit of Use | 00843997007061 | GS1 |
Customer Contacts
- Phone
- +1(949)297-7498
- [email protected]
Storage Conditions
- Type
- Handling Environment Humidity
- Temperature Range
- 15 – 95 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- -20 – 60 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 15 – 95 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 60 Degrees Celsius