FDA UDI
In Commercial Distribution
🇺🇸 United States
Cellu M6 Alliance Lab
DI: B534CELLUM6LABMED1
·
Model: Cellu M6 Alliance Lab Medical
·
L P G SYSTEMS
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Cellu M6 Alliance Lab
- Primary DI
- B534CELLUM6LABMED1
- Version / Model
- Cellu M6 Alliance Lab Medical
- Company Name
- L P G SYSTEMS
- Labeler DUNS
- 394430433
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-05-02
- Public Version
- 2
- Public Version Date
- 2024-06-06
- Public Version Status
- Update
- Public Device Record Key
- f7bfff95-6820-48cf-8f5b-84a36417cd13
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- 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
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| ISA | Massager, Therapeutic, Electric | Physical Medicine | 890.5660 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35538 | Freestanding electric massager | An electrically-powered benchtop, mobile, or stationary device designed to provide therapeutic massage to a larger area than hand-held massaging devices. It may be in the form of a vibrating bed or a tabletop/freestanding unit with a massaging handpiece or other interchangeable mechanisms that are applied to the body to mechanically stimulate the musculature or provide other physiotherapy treatment; it may additionally provide heat. This device is intended for use in healthcare facilities and is not applicable to home therapies. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B534CELLUM6LABMED1 | HIBCC |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 70 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 30 – 75 Percent (%) Relative Humidity