NRFit

Primary DI
10610586043970
Brand
NRFit
Company
ICU MEDICAL, INC.
Model
21-7639-24
Published
2017-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LHISet, i.V. Fluid transfer
PWHAdministrations sets with neuraxial connectors

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LHISet, I.V. Fluid TransferGeneral Hospital2
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
30610586043974PackageGS112In Commercial Distribution
10610586043970PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3061058604397430610586043974
1061058604397010610586043970

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
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10887709195162BivonaHT26FS45NGF051N2026-06-08
10887709195179BivonaFT26FN40NGF053N2026-06-08
10887709195186BivonaFT26FN35NGF054N2026-06-08
10887709195193BivonaFU26FN45NGF049N2026-06-08
10887709195209BivonaFT26FN60NGA046N2026-06-08
10887709195216BivonaFT26FN35NGE057N2026-06-08
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10887709195230BivonaFP26FN40NGC058N2026-06-08
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10887709195254BivonaFT26FN40NGE063N2026-06-08
10887709195261BivonaXT26FS60NGC064N2026-06-08
10887709195278BivonaFU26FN45NSF052N2026-06-08
10887709194967BivonaFT26FN40NSF031N2026-06-05
10887709194974BivonaFU26FN35NGF035N2026-06-05
10887709194981BivonaFU26FN40NGE036N2026-06-05
10887709194998BivonaXU26FS35NGA037N2026-06-05
10887709195001BivonaXU26FS35NGA038N2026-06-05

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