FDA.report

Fisherbrand

Primary DI
00613647024409
Brand
Fisherbrand
Company
FISHER SCIENTIFIC COMPANY L.L.C.
Model
FB3532DH
Catalog number
11676602
Device description
ISOTEMP DH CO2 TC 120V
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
00613647024409PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00613647024409006136470244096136470244090613647024409

GMDN Terms

TermDefinition
Carbon dioxide laboratory incubatorA mains electricity (AC-powered) incubator in which a fixed temperature and carbon dioxide (CO2) controlled conditions can be achieved and maintained. It is used for the incubation of biological and chemical materials. The percentage mixture of carbon dioxide and other gases, typically oxygen, can be different depending on the use and device type.

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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