FDA.reportPublic FDA data

CAB-VR™ Storage System

Primary DI
00841436122702
Brand
CAB-VR™ Storage System
Company
CIVCO MEDICAL INSTRUMENTS CO., INC.
Model
610-2420A
Catalog number
610-2420A
Device description
CAB-VR™ Storage System
Published
2022-10-28
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
HRECabinet, instrument, ac-powered, ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRECabinet, Instrument, Ac-Powered, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20841436122706Direct MarkingGS10
00841436122702PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2084143612270620841436122706
00841436122702008414361227028414361227020841436122702

GMDN Terms#

Term, Definition table
TermDefinition
Endoscope drying/storage cabinetAn electrically-powered enclosed chamber (the cabinet) designed to dry and store flexible endoscopes and their accessories in an environment that prevents bacterial growth. It uses high-efficiency particulate air (HEPA) inducted into the device and typically heated to 37º Celsius so that the pre-sterilized endoscopes are dried both inside and out. They are then stored within the cabinet under conditions to prevent re-contamination (e.g., under ultraviolet (UV) light) so that they can be directly used without a need for disinfection. It is equipped with a door(s) and shelves to accommodate multiple endoscopes, and is electronically controlled to regulate the drying/storage processes.

Contacts#

Phone, Email table
PhoneEmail
+1(319)248-6502regulatory@civco.com

Regulatory Flags#

DUNS number
134614411
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841436122061Verza Guidance System653-003653-0032026-07-23
00841436122672Needle Guide667-186667-1862026-07-23
00841436125338Biopsy Bracket667-195667-1952026-07-23
00841436125413Tracking Bracket Starter Kit657-106657-1062026-07-23
00841436125444Cradle657-108657-1082026-07-23
00841436125451Classic Stepper657-109657-1092026-07-23
00841436125819Biopsy Bracket642-522642-5222026-07-23
00841436125833Needle Guide Bracket642-524642-5242026-07-23
00841436125857Needle Guide Bracket642-526642-5262026-07-23
00841436126045Verza Guidance System657-110657-1102026-07-23
00841436126281Biopsy Bracket657-116657-1162026-07-23
00841436126304Biopsy Bracket657-118657-1182026-07-23
00841436126656Multi-Purpose Workstation ™ Stepper610-2561610-25612026-07-23
00841436126663Cradle610-2562610-25622026-07-23
00841436126670Storage System610-2559610-25592026-07-23
00841436126687Storage System610-2560610-25602026-07-23
10841436122662Needle Guide667-188667-188, 667-188-52025-12-31
00841436126311Tracking Bracket Starter Kit657-119657-1192025-12-31
00841436125482Needle Guide11820737118207372026-04-17
00841436108300TEE Kit811-050811-0502017-08-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841436126670Storage SystemCIVCO MEDICAL INSTRUMENTS CO., INC.HRE2026-07-23
00841436126687Storage SystemCIVCO MEDICAL INSTRUMENTS CO., INC.HRE2026-07-23
00841436122696CAB-TEE Storage SystemCIVCO MEDICAL INSTRUMENTS CO., INC.HRE2022-10-28
20841436122690CAB-TEE Storage SystemCIVCO MEDICAL INSTRUMENTS CO., INC.HRE2022-10-28
20841436122706CAB-VR™ Storage SystemCIVCO MEDICAL INSTRUMENTS CO., INC.HRE2022-10-28
00841436121156Cabinet Storage SystemCIVCO MEDICAL INSTRUMENTS CO., INC.HRE2021-11-20
00841436121163Cabinet Storage SystemCIVCO MEDICAL INSTRUMENTS CO., INC.HRE2021-11-20
00841436112369Cabinet Storage SystemCIVCO MEDICAL INSTRUMENTS CO., INC.HRE2018-09-25
00841436112376Cabinet Storage SystemCIVCO MEDICAL INSTRUMENTS CO., INC.HRE2018-09-25
20841436112363Cabinet Storage SystemCIVCO MEDICAL INSTRUMENTS CO., INC.HRE2018-09-25
20841436112370Cabinet Storage SystemCIVCO MEDICAL INSTRUMENTS CO., INC.HRE2018-09-25