FDA.report

Fisherbrand

Primary DI
00613647024577
Brand
Fisherbrand
Company
FISHER SCIENTIFIC COMPANY L.L.C.
Model
FSSWB15
Catalog number
FSSWB15
Device description
ISOTEMP 15L SHAKING 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
00613647024577PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00613647024577006136470245776136470245770613647024577

GMDN Terms

TermDefinition
Laboratory water bath/shakerA mains electricity (AC-powered) device designed with a heating element, thermostat and an automated shaking mechanism to heat and shake its contents (i.e., the water and objects placed therein, e.g., bottles containing cultures or trays of gel). This device has an eccentic agitation arm that rotates at speed ranges of, e.g., 25 - 400 revolutions per minute (rpm) to create the agitation. It may incorporate a range of features such as automatic water replenishment, heating and/or cooling, automatic motion acceleration to avoid unwanted splashing.

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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