FDA.report

Epredia

Primary DI
00673693220163
Brand
Epredia
Company
RICHARD-ALLAN SCIENTIFIC COMPANY
Model
UniSystem Slide-10
Catalog number
200209
Device description
The UniSystem tubes are disposable, polystyrene tubes graduated to 12 mL, with unique patented tips designed to retain a standardized 0.4 mL volume of sediment or liquid when decanted. Up to 10 tubes can be simultaneously decanted by using the UniSystem Rack or tubes can be individually decanted by hand.
Published
2024-07-31
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
true

Related Records

Product Codes

CodeName
IFBCytocentrifuge

Product Code Classifications

CodeDeviceSpecialtyClass
IFBCytocentrifugePathology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00673693220163PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00673693220163006736932201636736932201630673693220163

GMDN Terms

TermDefinition
Urine specimen collection kit IVDA collection of noninvasive devices intended to be used for the collection, preservation, and transport of a urine specimen for culture, analysis, and/or other investigation. It typically consists of a primary urine collection receptacle (e.g., cup, conical tube, vessel), a urine preservation/transport tube [typically evacuated, with or without additives], and a transfer device for facilitating the aseptic transfer of a urine sample between receptacles; supportive devices for urine collection (e.g., wet wipes, absorbent pads, Foley catheter connector) and/or analysis [e.g., microscope slides, tube rack] may also be included in the kit. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
929504710
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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