FDA.reportPublic FDA data

ICU Medical

Primary DI
00887709080126
Brand
ICU Medical
Company
ICU MEDICAL, INC.
Model
BX01LL
Catalog number
BX01LL
Device description
"130"" (330 cm) Heavy Duty Single Lead Set w/Clamp, 2 Luer Locks (Male/Male)"
Published
2021-08-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LHISet, i.V. Fluid transfer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LHISet, I.V. Fluid TransferGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K913804000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K913804000EXCELSIOR SINGLE LEAD DISPENSING SETExcel Medical, Inc.1992-02-11LHI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10887709080123PackageGS130In Commercial Distribution
00887709080126PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088770908012310887709080123
00887709080126008877090801268877090801260887709080126

GMDN Terms#

Term, Definition table
TermDefinition
Basic intravenous administration set, noninvasiveA collection of noninvasive devices intended to conduct fluids from an intravenous (IV) administration bag/bottle to a peripheral venous cannula (not included) during gravitational or pump administration to a patient's venous system; some types may in addition be intended for enteral feeding applications. It typically includes tubing, connectors, chambers, and clamps; the bag/bottle may be included. It neither includes devices intended for invasive use nor a heat exchanger. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(866)829-9025customerservice@icumed.com

Regulatory Flags#

DUNS number
118380146
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10887709199870BivonaFU26GN40NSC236N2026-07-30
10887709199887BivonaFU26GN30NSC235N2026-07-30
10887709199894BivonaFU26GN30NSF235N2026-07-30
10887709199689BivonaFU26GN60NGF229N2026-07-29
10887709199696BivonaFT26GN45NSF228N2026-07-29
10887709199702BivonaST26GN50NGF231N2026-07-29
10887709199719BivonaFT26GN40NGF230N2026-07-29
10887709199726BivonaFT26GN65NSC225N2026-07-29
10887709199733BivonaSU26GN45NSC223N2026-07-29
10887709199740BivonaSU26GN40NSC222N2026-07-29
10887709199757BivonaFT26GN60NSF232N2026-07-29
10887709199658BivonaFT26GN25NSA221N2026-07-28
10887709199665BivonaST26GN55NSB224N2026-07-28
10887709198804BivonaFT26GN45NSF145N2026-07-27
10887709199252BivonaFU26GN50NSF160N2026-07-27
10887709199269BivonaFT26GN55NGF161N2026-07-27
10887709199276BivonaFP26GN40NSF163N2026-07-27
10887709199283BivonaFU26GN45NSA164N2026-07-27
10887709199290BivonaFT26GN40NGE162N2026-07-27
10887709199306BivonaFT26FN80NSC026S2026-07-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10813153027384CodanCodan US CorporationLHI2026-06-25
08699443581898FlowArt®ASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETILHI2026-02-13
08699443581911FlowArt®ASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETILHI2026-02-13
08699443581928FlowArt®ASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETILHI2026-02-13
08699443585292FlowArt®ASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETILHI2026-02-13
08699443585308FlowArt®ASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETILHI2026-02-13
08699443585315FlowArt®ASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETILHI2026-02-13
08699443585322FlowArt®ASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETILHI2026-02-13
08699443585339FlowArt®ASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETILHI2026-02-13
10815879021929IV PlusNEXUS MEDICAL, LLCLHI2025-10-03
10815879021806 Nexus TKO®NEXUS MEDICAL, LLCLHI2024-10-21
08699443580174FlowArt®ASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETILHI2024-10-07
10815879021783IV PlusNEXUS MEDICAL, LLCLHI2024-09-27
10815879021745IV PlusNEXUS MEDICAL, LLCLHI2024-09-16
10815879021752IV PlusNEXUS MEDICAL, LLCLHI2024-09-16
08699443580167FlowArt®ASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETILHI2024-08-05
10815879021677 Nexus TKO®NEXUS MEDICAL, LLCLHI2024-04-02
10197344001699MedlineMEDLINE INDUSTRIES, INC.LHI2024-03-05
10815879021660IV PlusNEXUS MEDICAL, LLCLHI2024-03-05
10860009080505NavaClick Injection KitLineage Biomedical, Inc.LHI2024-01-30
10815879021547IV PlusNEXUS MEDICAL, LLCLHI2022-09-08
10193489896848Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LHI2022-08-04
10815879021523IV PlusNEXUS MEDICAL, LLCLHI2022-06-15
10612479261959McKessonMCKESSON MEDICAL-SURGICAL INC.LHI2022-02-24
10612479261973McKessonMCKESSON MEDICAL-SURGICAL INC.LHI2022-02-24
08426314778770GRI-FILL 6 to1 SetLABORATORIOS GRIFOLS SALHI2021-10-25
10815879021394IV PlusNEXUS MEDICAL, LLCLHI2021-02-26
10815879021295IV PlusNEXUS MEDICAL, LLCLHI2021-01-20
10850022888011Vial2Bag Advanced 20mmWest Pharmaceutical Services Az, Inc.LHI2020-12-23
10813153020330CodanCodan US CorporationLHI2017-11-30