FDA UDI
In Commercial Distribution
🇺🇸 United States
HistoSonics
DI: 00850006962068
·
Model: HISFL1001
·
Histosonics, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- HistoSonics
- Primary DI
- 00850006962068
- Version / Model
- HISFL1001
- Company Name
- Histosonics, Inc.
- Labeler DUNS
- 028153599
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-07-29
- Public Version
- 1
- Public Version Date
- 2024-08-06
- Public Version Status
- New
- Public Device Record Key
- 5a195d16-26eb-4d12-ac04-740f7419dd71
Device Description
Fluidics 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
- 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 |
|---|---|---|---|---|
| JRS | Purifier, Water (Absorption, Deionization, Membrane Filter, Reverse Osmosis) | Clinical Chemistry | 862.2050 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44344 | Combination water purification system | An assembly of electrically-powered devices, or stand-alone device, designed to remove unwanted chemical, particulate, and/or biological contaminants from water. This system purifies water using a combination of methods including particulate filtration, chemical disinfection, deionization, reverse osmosis, and/or ultraviolet light. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850006962068 | GS1 |
Customer Contacts
- Phone
- 8777400543
- [email protected]
Storage Conditions
- Type
- Handling Environment Humidity
- Temperature Range
- 30 – 75 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- 10 – 40 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 75 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -15 – 50 Degrees Celsius