FDA.report

Fisherbrand™ Isotemp™ Ultra-Low-Temperature Freezer

Primary DI
10816934022271
Brand
Fisherbrand™ Isotemp™ Ultra-Low-Temperature Freezer
Company
KEY SCIENTIFIC INC
Model
IUE50086LV
Catalog number
IUE50086LV
Device description
Isotemp Series -86C Freezer, 500 Box Capacity, 230V/50Hz
Published
2019-06-24
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

Product Codes

CodeName
KSERefrigerator, Freezer, Blood Storage

Product Code Classifications

CodeDeviceSpecialtyClass
KSERefrigerator, Freezer, Blood StorageHematology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10816934022271PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1081693402227110816934022271

GMDN Terms

TermDefinition
Ultralow-temperature laboratory freezerA mains electricity (AC-powered) freezer designed for the storage of laboratory products and sample materials, e.g., in vitro diagnostic (IVD) reagents and laboratory tissue/body fluid samples that require extremely low temperatures, usually in the range from -40 to -90? Celsius. It will typically have a corrosion resistant (typically stainless steel) interior minimizing the risk of adulteration, contamination, and/or corrosion of the contents and a shelving configuration appropriate for storage/easy localization of the products. It will typically be programmable, have defrost capabilities, a built-in alarm system to warn against temperature variations, and a recorder to record events.

Sterilization Methods

Method

Regulatory Flags

DUNS number
938286804
Device count
1
DM exempt
false
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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