FDA UDI
In Commercial Distribution
🇺🇸 United States
Epimed International, Inc.
DI: 00818788022295
·
Model: 401-PBSYS
·
EPIMED INTERNATIONAL, INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Epimed International, Inc.
- Primary DI
- 00818788022295
- Version / Model
- 401-PBSYS
- Company Name
- EPIMED INTERNATIONAL, INC
- Labeler DUNS
- 799751953
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-12-05
- Public Version
- 1
- Public Version Date
- 2025-12-15
- Public Version Status
- New
- Public Device Record Key
- 0093ddc7-8f94-4b7b-8860-a48afb02917d
Device Description
PainBlocker Console (CO²), Foot and Cart
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| GXH | DEVICE, SURGICAL, CRYOGENIC | Neurology | 882.4250 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 17140 | Cryogenic analgesia unit | A device designed to provide analgesia (the alleviation of pain) by applying extremely low temperatures (freezing) to body tissues. The device consists of a cryostat and cooling probe, and sometimes a peripheral nerve-block stimulator (nerve stimulator). This device will incorporate some method of protecting the tissue it is being applied to against permanent damage (e.g., freeze-thaw cycles). Cryogenic analgesia results in reversible, though prolonged (weeks/months), peripheral nerve-block and is used for postoperative and chronic intractable pain relief. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00818788022295 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K854334 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 50 – 90 Degrees Fahrenheit