FDA.reportPublic FDA data

ADD-Vantage

Primary DI
10887787001676
Brand
ADD-Vantage
Company
ICU Medical, Inc.
Model
1141001
Catalog number
1141001
Device description
ADD-Vantage ADDaptor Connector, Non-DEHP
Published
2016-09-20
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

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
K133602000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K133602000ADD-VANTAGE ADDAPTORHospira, Inc.2014-01-24LHI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30887787001670PackageGS125In Commercial Distribution
10887787001676PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3088778700167030887787001670
1088778700167610887787001676

GMDN Terms#

Term, Definition table
TermDefinition
Fluid transfer set, general-purposeA collection of devices and supplies designed to transfer several types of medical fluids (e.g., drugs, vaccines, blood, and solutions) between a first container(s) [e.g., a vial(s)] and a second container [e.g., an intravenous (IV) bag]; it is not dedicated to a particular type of fluid or clinical procedure. It is available in a variety of configurations and typically includes tubes, connectors, spike(s), syringes, and caps. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Room Temperature. Avoid Excessive Heat. Protect from Freezing

Contacts#

Phone, Email table
PhoneEmail
+1(877)946-7747uscustomercare@pfizer.com

Regulatory Flags#

DUNS number
830767898
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
10887709206622BivonaZT26JN45NSF109N2026-10-26
10887709206639BivonaZT26JN40NSE108N2026-10-26
10887709206790BivonaZU26JN60NSC128N2026-10-26
10887709206806BivonaST22LN60NSZ210N2026-10-26
10887709207025BivonaSA26JN95ZSC110N2026-10-26
10887709207384BivonaFT26JN35NGA179N2026-10-26
10887709207391BivonaFU26JN35NGA180N2026-10-26
10887709207438BivonaFT26JN50NSA183N2026-10-26
10887709146966LifeShield Infusion Safety Software Suite - DFM17002-032026-10-23
10887709146973LifeShield Infusion Safety Software Suite - DLM17003-032026-10-23
10887709146980LifeShield Infusion Safety Software Suite - CDR17005-032026-10-23
10887709155050LifeShield Infusion Safety Software Suite17000-032026-10-23
10887709207230BivonaFU26JN50NSF167N2026-10-23
10887709207247BivonaFU26JN40NSF171N2026-10-23
10887709207254BivonaFT26JN35NGF170N2026-10-23
10887709207261BivonaFT26JN40NSA166N2026-10-23
10887709207278BivonaFU26JN55NGF168N2026-10-23
10887709207339BivonaFT26JN30NGE178N2026-10-23
10887709207346BivonaFT26JN35NGF174N2026-10-23
10887709207353BivonaFT26JN35NGF175N2026-10-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00887709190207ICU Medical, Inc.ICU MEDICAL, INC.LHI2026-08-07
00887709190214ICU Medical, Inc.ICU MEDICAL, INC.LHI2026-08-07
18859299138111ADRx Admixture SystemEPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDLHI2026-08-01
18859299138128ADRx Admixture SystemEPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDLHI2026-08-01
18859299138326ADRx Admixture SystemEPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDLHI2026-08-01
00840117349841IV Administration Sets, Non-Toxic, 20 Drops/mL, 84" (213.4 cm)Dynarex CorporationLHI2026-06-30
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
04063574200425nextaro® va 13, 5 µm Filtersfm medical devices GmbHLHI2025-09-05
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
04063574200371nextaro® va 15, 5 µm Filtersfm medical devices GmbHLHI2024-09-11
04063574200401nextaro® 20/20, vented, 5 µm Filtersfm medical devices GmbHLHI2024-09-11
08699443580167FlowArt®ASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETILHI2024-08-05
04063574200357nextaro® 20/32, vented, 15 µm nominal Filtersfm medical devices GmbHLHI2024-06-05
04063574200272nextaro® 20/20, vented, 15 µm nominal Filtersfm medical devices GmbHLHI2024-04-24
10815879021677 Nexus TKO®NEXUS MEDICAL, LLCLHI2024-04-02
10197344001699MedlineMEDLINE INDUSTRIES, INC.LHI2024-03-05
10815879021660IV PlusNEXUS MEDICAL, LLCLHI2024-03-05