FDA.report

Fisherbrand

Primary DI
00613647024522
Brand
Fisherbrand
Company
FISHER SCIENTIFIC COMPANY L.L.C.
Model
FSGPD10
Catalog number
FSGPD10
Device description
ISOTEMP 10L GP BATH
Published
2022-09-21
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
00613647024522PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00613647024522006136470245226136470245220613647024522

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(724)517-2425regulatory.affairs@thermofisher.com

Regulatory Flags

DUNS number
004321519
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
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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