FDA.reportPublic FDA data

Scanning Kit

Primary DI
10841436103623
Brand
Scanning Kit
Company
CIVCO MEDICAL INSTRUMENTS CO., INC.
Model
610-224
Catalog number
610-224
Device description
Non-sterile extension tube, (60cc) syringe and 3-way stopcock
Published
2017-08-22
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IYDGenerator, low voltage, therapeutic x-ray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYDGenerator, Low Voltage, Therapeutic X-RayRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K895614000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K895614000CIVCO LATEX ULTRASOUND SHEATHSCIVCO Medical Instruments Co., Inc.1989-12-14IYO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841436103626PackageGS15Not in Commercial Distribution
10841436103623PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841436103626008414361036268414361036260841436103626
1084143610362310841436103623

GMDN Terms#

Term, Definition table
TermDefinition
Body-surface ultrasound imaging transducer coverA device/material intended to be used as a physical barrier for protection against the effects of environmental exposure (e.g., body fluids, gels) and/or to maintain the required hygienic level of an ultrasound system imaging transducer (probe) used on the body surface during an ultrasound examination. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length6.37Inch
Total Volume60Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Away from Sunlight
Storage Environment Temperature52 Degrees Fahrenheit85 Degrees Fahrenheit

Contacts#

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

Regulatory Flags#

DUNS number
134614411
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration 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
10841436106174Needle GuideCIVCO MEDICAL INSTRUMENTS CO., INC.IYD2017-08-22
00841436103626Scanning KitCIVCO MEDICAL INSTRUMENTS CO., INC.IYD2017-08-22