FDA UDI
In Commercial Distribution
🇺🇸 United States
HACH
DI: 00851575007181
·
Model: 9730100
·
HACH COMPANY
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- HACH
- Primary DI
- 00851575007181
- Version / Model
- 9730100
- Catalog Number
- 9730100
- Company Name
- HACH COMPANY
- Labeler DUNS
- 091381780
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-05-12
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- e9fe55f9-d59f-4b52-a5ff-1a4b87dd1f3e
Device Description
REMOTE INDICATOR ASSY, CM130
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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 |
|---|---|---|---|---|
| PSX | Chlorine Meter | Gastroenterology, Urology | 876.5665 | 2 |
| FIP | Subsystem, Water Purification | Gastroenterology, Urology | 876.5665 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62446 | Haemodialysis system chlorine monitor | A mains electricity (AC-powered) component of a haemodialysis system intended to continuously measure total chlorine (total chloramines plus free chlorine) levels in water used to prepare dialysate. It performs sample collection and consists of an automated electronic assembly with a photometric colorimeter, chemical reagents which produce a colour change upon reaction with chlorine/chloramine, a stir motor, and a digital display screen to indicate chlorine concentration. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00851575007181 | GS1 |
Customer Contacts
- Phone
- 800-227-4224
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K162471 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 60 Degrees Celsius