FDA.report

CATALINA WATER BATH 2000 110V Serial Number:

Primary DI
D248429040
Brand
CATALINA WATER BATH 2000 110V Serial Number:
Company
HAGER WORLDWIDE, INC.
Model
42904
Device description
Dental lab water bath for softening wax
Published
2023-08-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
JTQBATH, INCUBATORS/WATER, ALL

Product Code Classifications

CodeDeviceSpecialtyClass
JTQBath, Incubators/Water, AllMicrobiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D248429040PrimaryHIBCC0

GMDN Terms

TermDefinition
Laboratory water bathA mains electricity (AC-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) container that can store water, heating elements, sensors, thermostats, and controls; some types incorporate refrigerating and/or stirring/agitating capabilities. It varies in size from a few to several hundred litres; it is used in various clinical laboratory procedures and may supply tempered water to lab equipment via a pump.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(828)624-3319d.pritchard@hagerworldwide.com

Regulatory Flags

DUNS number
009277971
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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