FDA UDI
In Commercial Distribution
🇺🇸 United States
Leak Detection System
DI: B297ACLD10000
·
Model: A-C-LD-1000
·
SPECIALITY WATER TECHNOLOGY
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Leak Detection System
- Primary DI
- B297ACLD10000
- Version / Model
- A-C-LD-1000
- Company Name
- SPECIALITY WATER TECHNOLOGY
- Labeler DUNS
- 032528935
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-04-11
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- f29894b9-e83d-47a4-9dc0-13bc7fd303b4
Device Description
Leak Detection System with audible alarm, call notification, manual reset
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
- No
- 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 |
|---|---|---|---|---|
| FIP | Subsystem, Water Purification | Gastroenterology, Urology | 876.5665 | 2 |
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 | B297ACLD10000 | HIBCC |
Customer Contacts
- Phone
- 615-654-4441
- [email protected]