FDA.reportPublic FDA data

CAB-TEE Storage System

Primary DI
00841436122696
Brand
CAB-TEE Storage System
Company
CIVCO MEDICAL INSTRUMENTS CO., INC.
Model
610-2419A
Catalog number
610-2419A
Device description
CAB-TEE 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
20841436122690Direct MarkingGS10
00841436122696PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2084143612269020841436122690
00841436122696008414361226968414361226960841436122696

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
00841436125482Needle Guide11820737118207372026-04-17
00841436108300TEE Kit811-050811-0502017-08-22
00841436108317TEE Kit811-051811-0512017-08-22
00841436108324TEE Kit811-052811-0522017-08-22
00841436108331TEE Kit811-053811-0532017-08-22
00841436108348TEE Kit811-054811-0542017-08-22
00841436108355TEE Kit811-055811-0552017-08-22
00841436108362TEE Kit811-056811-0562017-08-22
00841436108379TEE Kit811-057811-0572017-08-22
00841436111133Laparostat810-212810-2122017-08-22
10841436122655Needle Guide667-187667-1872025-12-31
10841436122662Needle Guide667-188667-1882025-12-31
10841436126240Needle Guide610-1557610-15572025-12-31
10841436126257Needle Guide610-1558610-15582025-12-31
00841436122894Verza Guidance System639-064639-0642025-12-31
00841436125345Verza Guidance System667-196667-1962025-12-31
00841436125802Verza Guidance SystemH48062APH48062AP2025-12-31
00841436125826Needle Guidance SystemH48062ARH48062AR2025-12-31
00841436125840Needle Guidance SystemH48062ASH48062AS2025-12-31
00841436126274Verza Guidance System657-115657-1152025-12-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841436122702CAB-VR™ 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