FDA UDI
Not in Commercial Distribution
🇺🇸 United States
BioMed Revived
DI: 00857771003965
·
Model: Revived
·
BIOMEDICAL LIFE SYSTEMS, INC.
Product Codes
1
GMDN Terms
2
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- BioMed Revived
- Primary DI
- 00857771003965
- Version / Model
- Revived
- Catalog Number
- BRVE
- Company Name
- BIOMEDICAL LIFE SYSTEMS, INC.
- Labeler DUNS
- 116956807
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-11-11
- Public Version
- 12
- Public Version Date
- 2023-06-02
- Public Version Status
- Update
- Public Device Record Key
- 34cbe67e-b40e-44bf-9ed1-773413653652
- Distribution End Date
- 2019-09-13
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NUH | Stimulator, Nerve, Transcutaneous, Over-The-Counter | Neurology | 882.5890 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35372 | Analgesic transcutaneous electrical nerve stimulation system | An assembly of electrically-powered devices designed to reduce the perception of pain by electrically stimulating peripheral nerves across the skin [transcutaneous electrical nerve stimulation (TENS)]. It includes an external current generator and skin-surface electrodes. It typically includes several predetermined stimulation options and is often worn on a belt or carried in a pocket of the user. It is intended for use in the home and healthcare facility to treat pain from surgery, trauma, musculoskeletal problems/arthritis, bursitis, dental problems, and may be used in physical therapy and during labour/delivery. | No | Active |
| 46573 | Physical therapy transcutaneous neuromuscular electrical stimulation system | An electrically-powered device assembly intended to apply various modes of electrical stimulation transcutaneously to treat/prevent neuromuscular symptoms and disorders typically as a form of physical therapy [neuromuscular electrical stimulation (NMES)/electronic muscle stimulation (EMS)]; it may in addition be intended for transcutaneous electrical nerve stimulation (TENS) to treat pain, and/or electroacupuncture. It includes an electric current pulse generator and noninvasive electrodes; it is not intended for tremor suppression. Clinical applications typically include relaxation/re-education of muscles, prevention of muscle atrophy, and improvement of blood circulation. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00857771003965 | GS1 | ||||
| Package | 10857771003962 | GS1 | case | 40 | Not in Commercial Distribution | 2019-09-13 |
Customer Contacts
- Phone
- 7607275600
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K141299 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Height | 5 | Inch | |
| Width | 2 | Inch | |
| Length | 7.5 | Inch |