FDA UDI
In Commercial Distribution
🇺🇸 United States
Radius VSM
DI: 10843997007655
·
Model: 4827
·
MASIMO CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
20
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Basic Information
- Brand Name
- Radius VSM
- Primary DI
- 10843997007655
- Version / Model
- 4827
- Company Name
- MASIMO CORPORATION
- Labeler DUNS
- 780421038
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 20
- Record Status
- Published
- Publish Date
- 2024-08-19
- Public Version
- 1
- Public Version Date
- 2024-08-27
- Public Version Status
- New
- Public Device Record Key
- 14c69d0c-b040-4f6d-a3a7-cc780b7042f9
Device Description
Radius VSM Disposable NIBP Cuff, Large Adult, 20/box
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
- 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 |
|---|---|---|---|---|
| DXQ | blood pressure cuff | Cardiovascular | 870.1120 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37326 | Blood pressure cuff, single-use | A band-like device that has an inflatable bladder in an inelastic sleeve with one or two connecting tubes with connector (typically locking connectors) that can be connected to a mechanism for inflating and deflating the bladder and/or a sphygmomanometer or a patient monitoring device/system that is used to determine a patient's blood pressure. It is typically wrapped around the upper arm of the patient. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00843997007658 | GS1 | ||||
| Primary | 10843997007655 | GS1 |
Customer Contacts
- Phone
- +1(949)297-7498
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K223498 | 000 |
Storage Conditions
- Type
- Handling Environment Humidity
- Temperature Range
- 5 – 95 Percent (%) Relative Humidity
- Type
- Storage Environment Humidity
- Temperature Range
- 5 – 95 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- 0 – 40 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- -40 – 60 Degrees Celsius