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
00841436125420Tracking Bracket657-107657-1072026-07-27
00841436126212Tracking Bracket Starter Kit657-113657-1132026-07-27
00841436126229Tracking Bracket657-114657-1142026-07-27
00841436126328Tracking Bracket657-120657-1202026-07-27
00841436126588Tracking Bracket Starter KitH4927NFH4927NF2026-07-27
00841436126595Tracking Bracket642-528642-5282026-07-27
00841436125413Tracking Bracket Starter Kit657-106657-1062026-07-23
10841436101865eTRAX™ Needle610-1057610-10572017-08-29
10841436101889VirtuTRAX Instrument Navigator610-1059610-10592017-08-22
10841436102282VirtuTRAX Instrument Navigator610-1153610-11532017-08-22
10841436102435eTRAX™ Needle610-1213-10610-1213-102017-08-29
10841436102534eTRAX™ Needle610-1217-10610-1217-102017-08-29
10841436102640omniTRAX Patient Tracker610-1228610-12282017-08-22
10841436103128omniTRAX Active Patient Tracker610-1306610-13062017-08-22
10841436103289eTRAX™ Needle610-1413-10610-1413-102017-08-29
10841436103302eTRAX™ Needle610-1417-10610-1417-102017-08-29
10841436103395eTRAX™ Needle610-1613-10610-1613-102017-08-29
10841436103418eTRAX™ Needle610-1615-10610-1615-102017-08-29
10841436103531eTRAX™ Needle610-1815-10610-1815-102017-08-29
10841436103555eTRAX™ Needle610-1818-10610-1818-102017-08-29

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