Sigma Virocult MW950S3

GUDID 25060259070512

Sigma Virocult 3 x swabs with breakpoint, large vial

MEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITED

General specimen collection kit IVD, clinical
Primary Device ID25060259070512
NIH Device Record Key7dcf62a7-9ae4-482e-bfbd-70bbd9b79115
Commercial Distribution StatusIn Commercial Distribution
Brand NameSigma Virocult
Version Model NumberN/a
Catalog NumberMW950S3
Company DUNS216096750
Company NameMEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITED
Device Count125
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS105060259070518 [Primary]
GS125060259070512 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LIODevice, Specimen Collection

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-10-13
Device Publish Date2023-10-05

On-Brand Devices [Sigma Virocult]

15060259076074Sigma Virocult + swab, breakpoint + 1 ml of VTM small vial
25060259074831Mini Sigma Virocult, Screw Vial, 2ml Virocult, Mini Foam
25060259074824Mini Sigma Virocult, Foam Swabs, 1Mini & 1Std, 3 ml Virocult
25060259074817Mini Sigma Virocult screw vial 3ml Medium foam swab
25060259074770Sigma virocult, screw vial 2ml virocult
25060259072707Sigma Virocult, swab with breakpoint, large vial 3ml
25060259072615Mini Sigma Virocult, 1 x Mini Foam 78mm & 1 x Std Foam 79mm
25060259072608Mini Sigma Virocult, Screw Vial, 2ml Virocult, Foam Swab
25060259072592mini Sigma Virocult, 2 x sigma swab, 1 white 1 red, 1ml VTM
25060259070567Mini Sigma Virocult, Screw Vial, 1ml Virocult, Mini Foam
25060259070550Mini Sigma Virocult, Screw Vial, 1ml Virocult, Foam Swab
25060259070536Sigma Virocult, 1 x Mini Foam 78mm BP & 1 x Std Foam 79mm BP
25060259070529Sigma Virocult Sigma ENT breakpoint + 2ml VTM large vial
25060259070512Sigma Virocult 3 x swabs with breakpoint, large vial
25060259070505Sigma Virocult 2x swabs and breakpoint, large vial 2ml
25060259070499Sigma Virocult + swab with breakpoint , large vial 2ml

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