FDA UDI
In Commercial Distribution
🇺🇸 United States
Epimed
DI: 00818788022714
·
Model: 400-PBCRT
·
EPIMED INTERNATIONAL, INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Epimed
- Primary DI
- 00818788022714
- Version / Model
- 400-PBCRT
- Catalog Number
- 400-PBCRT
- Company Name
- EPIMED INTERNATIONAL, INC
- Labeler DUNS
- 799751953
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-10-27
- Public Version
- 4
- Public Version Date
- 2023-12-15
- Public Version Status
- Update
- Public Device Record Key
- d782578a-09cf-4e6b-9986-8412fff49b66
Device Description
PainBlocker™ Cart
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 Unsafe
- Direct Marking Exempt
- Yes
- PM Exempt
- Yes
- Has Serial Number
- Yes
- 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 |
|---|---|---|---|---|
| GXH | DEVICE, SURGICAL, CRYOGENIC | Neurology | 882.4250 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66881 | Surgical/procedural instrument transport cabinet | An enclosed mobile cart intended for the storage and transportation of surgical/medical instruments within a healthcare facility (e.g., between operating and central sterilization rooms). It is in the form of a cupboard on wheels with internal shelves/drawers. It is not intended to be used for sterilization of instruments. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00818788022714 | GS1 |
Customer Contacts
- Phone
- +1(800)866-3342
- [email protected]
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 50 – 90 Degrees Fahrenheit