FDA.reportPublic FDA data

CADD

Primary DI
10610586044755
Brand
CADD
Company
ICU MEDICAL, INC.
Model
21-7684-24
Published
2021-12-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
PWHAdministrations sets with neuraxial connectors

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PWHAdministrations Sets With Neuraxial ConnectorsGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K162219000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162219000CADD® Infusion Disposables Portfolio with NRFit™ connectorsSmiths Medical Asd, Inc.2017-07-20PWH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30610586044759PackageGS115In Commercial Distribution
10610586044755PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3061058604475930610586044759
1061058604475510610586044755

GMDN Terms#

Term, Definition table
TermDefinition
Electric infusion pump administration set, single-useA collection of sterile devices (e.g., plastic tubing, check valve, roller clamp, Y-site connector, Luer, needle/catheter) intended to be used in combination with an electrically-powered infusion pump for the intravenous (IV), subcutaneous, intramuscular, or epidural administration of medication. This is a single-use device.

Regulatory Flags#

DUNS number
118380146
Device count
1
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10887709199061BivonaFT26GN50NGF159N2026-07-22
10887709198095BivonaFT26GN40NGF059N2026-07-21
10887709198521BivonaST26GN65NSC093N2026-07-21
10887709198897BivonaHT26GS50NSC139N2026-07-21
10887709198903BivonaHU26GS50NSC140N2026-07-21
10887709198910BivonaFU26GN45NSF142N2026-07-21
10887709198927BivonaFT26GN60NSF137N2026-07-21
10887709198934BivonaFT26GN70NSC136N2026-07-21
10887709198965BivonaXT26GS60NGF149N2026-07-21
10887709198972BivonaFT26GN40NSF150N2026-07-21
10887709198996BivonaFU26GN40NSF151N2026-07-21
10887709199009BivonaFT26GN45NSF147N2026-07-21
10887709199016BivonaFU26GN50NSF146N2026-07-21
10887709199023BivonaFU26GN45NGF148N2026-07-21
10887709199030BivonaFU26GN30NGE153N2026-07-21
10887709199047BivonaFU26GN35NGE152N2026-07-21
10887709199054BivonaXU26GS45NGF154N2026-07-21
10887709198491BivonaSU26EN50NGF192S2026-07-20
10887709198507BivonaSU26GN40NGF092N2026-07-20
10887709198514BivonaFT26GN60NSC091N2026-07-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
30610586044759CADDSmiths Medical ASD, Inc.PWH2021-12-07
15019517184242CADDICU MEDICAL, INC.PWH2020-03-06
15019517184259CADDICU MEDICAL, INC.PWH2020-03-06
35019517184246CADDSmiths Medical ASD, Inc.PWH2020-03-06
35019517184253CADDSmiths Medical ASD, Inc.PWH2020-03-06
10610586043826NRFitICU MEDICAL, INC.PWH2017-09-21
10610586043833NRFitICU MEDICAL, INC.PWH2017-09-21
10610586043840NRFitICU MEDICAL, INC.PWH2017-09-21
10610586043970NRFitICU MEDICAL, INC.PWH2017-09-21
10610586043994NRFitICU MEDICAL, INC.PWH2017-09-21
10610586044007NRFitICU MEDICAL, INC.PWH2017-09-21
10610586044014NRFitICU MEDICAL, INC.PWH2017-09-21
10610586044021NRFitICU MEDICAL, INC.PWH2017-09-21
10610586044113NRFitICU MEDICAL, INC.PWH2017-09-21
10610586044748NRFitICU MEDICAL, INC.PWH2017-09-21
30610586043820NRFitICU MEDICAL, INC.PWH2017-09-21
30610586043837NRFitICU MEDICAL, INC.PWH2017-09-21
30610586043844NRFitICU MEDICAL, INC.PWH2017-09-21
30610586043974NRFitICU MEDICAL, INC.PWH2017-09-21
30610586043998NRFitICU MEDICAL, INC.PWH2017-09-21
30610586044001NRFitICU MEDICAL, INC.PWH2017-09-21
30610586044018NRFitICU MEDICAL, INC.PWH2017-09-21