FDA UDI
In Commercial Distribution
🇺🇸 United States
CATALINA WATER BATH 2000 110V Serial Number:
DI: D248429040
·
Model: 42904
·
HAGER WORLDWIDE, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- CATALINA WATER BATH 2000 110V Serial Number:
- Primary DI
- D248429040
- Version / Model
- 42904
- Company Name
- HAGER WORLDWIDE, INC.
- Labeler DUNS
- 009277971
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-08-10
- Public Version
- 2
- Public Version Date
- 2023-09-18
- Public Version Status
- Update
- Public Device Record Key
- 29c6ca6d-37f5-48ee-bed9-f2ca1aa95e06
Device Description
Dental lab water bath for softening wax
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| JTQ | BATH, INCUBATORS/WATER, ALL | Microbiology | 866.2540 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36754 | Laboratory water bath | An electrically-powered receptacle for water designed to immerse and keep objects or products at a hot, or less frequently, cold temperature; typically the temperature can be controlled from a few degrees below or above ambient temperature to close to 100° Celsius (212° Fahrenheit). It typically consists of a corrosion-resistant (e.g., stainless steel) water container, heating elements, sensors, thermostats, and controls; some types incorporate refrigerating and/or stirring/agitating capabilities. It is used in various clinical laboratory procedures (e.g., paraffin wax-embedded tissue specimen flotation) and may supply tempered water to lab equipment via a pump. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D248429040 | HIBCC |
Customer Contacts
- Phone
- +1(828)624-3319
- [email protected]