FDA UDI
In Commercial Distribution
🇺🇸 United States
ReDS System
DI: 07290110070113
·
Model: V2.6
·
SENSIBLE MEDICAL INNOVATIONS LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ReDS System
- Primary DI
- 07290110070113
- Version / Model
- V2.6
- Catalog Number
- SAS0120
- Company Name
- SENSIBLE MEDICAL INNOVATIONS LTD
- Labeler DUNS
- 532269045
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-08-22
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 72fa7d68-6566-4a69-bdec-c24e278ab349
Device Description
Clinicl Kit including magnet, pins and caps for vest adjustment locking, to enable shipment of extra parts to the clinic (Related to ReDS Wearable System).
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
- 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DSB | Plethysmograph, Impedance | Cardiovascular | 870.2770 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35242 | Whole-body plethysmograph | A graphic recorder designed for determining and registering airway resistance and thoracic gas volume to assess pulmonary function. It includes an airtight body chamber and transducers that allow the recording of chamber pressure versus airflow, and chamber pressure versus mouth pressure, to determine the airway resistance. Thoracic gas volume is typically determined by recording the chamber and airway pressures simultaneously with the airway open and with the airway occluded. It may also be possible to determine the instantaneous flow by recording the pulmonary capillary blood flow with the device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07290110070113 | GS1 |
Customer Contacts
- Phone
- 855.899.7951
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K150095 | 000 |