FDA.report

E8 Combination Centrifuge, fixed speed

Primary DI
00664816003459
Brand
E8 Combination Centrifuge, fixed speed
Company
LW SCIENTIFIC, INC.
Model
E8C-U8AF-CR03
Device description
E8 Combination Centrifuge, fixed speed, for 3-15ml test tubes and 75mm hematocrit tubes, with crit carrier and reader card
Published
2019-04-01
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
GKGCentrifuge, Hematocrit

Product Code Classifications

CodeDeviceSpecialtyClass
GKGCentrifuge, HematocritHematology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00664816003459PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00664816003459006648160034596648160034590664816003459

GMDN Terms

TermDefinition
Microhaematocrit centrifugeA tabletop- or bench-mounted mains electricity (AC-powered) device used mainly in the clinical laboratory to process through high-speed centrifugal force (typically 10,000 to 25,000 rpm) specimens of whole blood to determine the ratio of the red cell volume to the whole blood volume expressed as a decimal, fraction, or percentage. The device typically generates a relative centrifugal force (RCF) of at least 10,000 x g to efficiently pack cells in a short time (i.e., 3 to 5 minutes) and requires a smaller sample size than low-speed conventional centrifuges (macrohaematocrit method). The haematocrit is typically used to diagnose blood loss and erythrocyte count above or below normal.

Sterilization Methods

Method

Regulatory Flags

DUNS number
785335381
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
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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04050674030151Swing-out rotorAndreas Hettich GmbH & Co. KGGKG2021-09-02
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04050674077316Swing-out rotorAndreas Hettich GmbH & Co. KGGKG2021-09-02