NRFit

Primary DI
30610586044018
Brand
NRFit
Company
ICU MEDICAL, INC.
Model
21-7609-24
Published
2017-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
30610586044018PackageGS112In Commercial Distribution
10610586044014PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3061058604401830610586044018
1061058604401410610586044014

GMDN Terms#

Term, Definition table
TermDefinition
Infusion pump cassetteA sterile device designed to be used in conjunction with an infusion pump or a device containing an infusion pump (e.g., a physiology-monitoring sedation system, physiology-monitoring anaesthesia system), for the delivery of an intravenous (IV) medication (e.g., a sedative or anaesthetic) contained within an independent drug vial. The cassette is inserted into the infusion pump and the drug vial is inserted into the cassette; the cassette tubing interfaces with the pump drive mechanism for medication delivery through connection with an infusion administration set. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
118380146
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10887709195131BivonaST26FN50NGF055N2026-06-08
10887709195148BivonaFT25LN30NGF157N2026-06-08
10887709195155BivonaFT26FN35NSF050N2026-06-08
10887709195162BivonaHT26FS45NGF051N2026-06-08
10887709195179BivonaFT26FN40NGF053N2026-06-08
10887709195186BivonaFT26FN35NGF054N2026-06-08
10887709195193BivonaFU26FN45NGF049N2026-06-08
10887709195209BivonaFT26FN60NGA046N2026-06-08
10887709195216BivonaFT26FN35NGE057N2026-06-08
10887709195223BivonaFT26FN30NGE056N2026-06-08
10887709195230BivonaFP26FN40NGC058N2026-06-08
10887709195247BivonaFT26FN35NSF059N2026-06-08
10887709195254BivonaFT26FN40NGE063N2026-06-08
10887709195261BivonaXT26FS60NGC064N2026-06-08
10887709195278BivonaFU26FN45NSF052N2026-06-08
10887709194967BivonaFT26FN40NSF031N2026-06-05
10887709194974BivonaFU26FN35NGF035N2026-06-05
10887709194981BivonaFU26FN40NGE036N2026-06-05
10887709194998BivonaXU26FS35NGA037N2026-06-05
10887709195001BivonaXU26FS35NGA038N2026-06-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10610586044755CADDICU MEDICAL, INC.PWH2021-12-07
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