FDA.reportPublic FDA data

Colibri Spreader

Primary DI
18050148212864
Brand
Colibri Spreader
Company
COPAN WASP SRL
Model
WR090-01-0605T
Catalog number
WR090-01-0605T
Device description
Colibri Spreader
Published
2022-11-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LONSystem, Test, Automated, Antimicrobial Susceptibility, Short Incubation
QBNMass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates
QQVAutomated System For Sample Preparation And Identification Of Microorganisms From Cultured Isolates By Mass Spectrometry

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LONSystem, Test, Automated, Antimicrobial Susceptibility, Short IncubationMicrobiology2
QBNMass Spectrometry, Maldi Tof, Microorganism Identification, Cultured IsolatesMicrobiology2
QQVAutomated System For Sample Preparation And Identification Of Microorganisms From Cultured Isolates By Mass SpectrometryMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K220546000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220546000Colibrí SystemCopan Wasp Srl2022-10-05LON

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18050148212864PrimaryGS10
58050148212862Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1805014821286418050148212864
5805014821286258050148212862

GMDN Terms#

Term, Definition table
TermDefinition
Inoculating tool IVD, analyser/instrumentA component of an automated/semi-automated in vitro diagnostic laboratory analyser or instrument intended to be used onboard to collect, transfer and spread an inoculum from a clinical specimen and/or culture isolate onto/into a culture medium (e.g., agar or broth) for subsequent in vitro diagnostic processing and/or testing. It is typically made of sterilizable materials (e.g., plastic, metal) and consists of a shaft with a loop, wand, or swab at one or both ends. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+390302687218wasp@copangroup.com

Regulatory Flags#

DUNS number
434263590
Device count
2
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
58059796363919Slide Prep Evo™W086-40NW086-40N2026-02-26
58059796363926Pipettor ModuleW086-090W086-0902026-02-26
58050148211438WASPLab® Single IncubatorW087-011W087-0112021-04-27
58050148211445WASPLab® Double IncubatorW087-012W087-0122021-04-27
58050148211476WASPLab® ConveyorW087-010W087-0102021-04-27
58050148212060WASPLab®W087W0872021-04-27
58050148218277Pipettor ModuleW086-090W086-0902021-04-27
58050148218970Slide Prep Evo™W086-40NW086-40N2021-04-27
58059796360857PhenoMATRIXWLAB-PHENOMATRIXWLAB-PHENOMATRIX2026-02-13
18050148217975Colibrí™ Primary Tube with WaterWR090-01-0003WR090-01-00032024-01-31
18052870817966Colibrí™ Primary Tube with SalineWR090-01-0011WR090-01-00112024-01-31
58059796363506WASP®W086W0862024-11-21
58050148211414WASP®W086W0862021-04-27
58059796363933WASPLab®W087W0872024-06-04
58059796363940WASPLab® ConveyorW087-010W087-0102024-06-04
58059796363957WASPLab® Single IncubatorW087-011W087-0112024-06-04
58059796363964WASPLab® Double IncubatorW087-012W087-0122024-06-04
58050148217973Colibrí™ Primary Tube with WaterWR090-01-0003WR090-01-00032024-01-31
58052870817964Colibrí™ Primary Tube with SalineWR090-01-0011WR090-01-00112024-01-31
08050148218005Colibri Daily Verification KitWR090-01-0004WR090-01-00042022-11-15

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