FDA.reportPublic FDA data

NA

Primary DI
00085412034690
Brand
NA
Company
BAXTER INTERNATIONAL INC.
Model
2C0463
Catalog number
2C0463
Device description
Solution Transfer Set, Large Bore Tubing, Two Spike Connectors
Published
2016-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NEPSYSTEM/DEVICE, PHARMACY COMPOUNDING

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NEPSystem/Device, Pharmacy CompoundingGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50085412034695PackageGS148Not in Commercial Distribution
00085412034690PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5008541203469550085412034695
00085412034690000854120346900854120346900085412034690

GMDN Terms#

Term, Definition table
TermDefinition
Intravenous administration bag/bottleAn empty pouch or bottle made of plastic or glass intended to contain a fluid (e.g., saline, medication) for intravenous (IV) administration; some types may in addition be intended for enteral feeding applications. It may be composed of one or more chambers and might be provided with a short length of tubing; however, it does not include other associated items (e.g., clamp, spike) [i.e., not an IV administration set] and is not intended to be directly connected to the IV catheter. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(800)933-0303Medinfo_medproducts@baxter.com

Regulatory Flags#

DUNS number
005146311
Device count
1
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00085412088303V-LINK/VITALSHIELD6N83996N83992016-09-24
00085412091785ONE-LINK7N83997N83992016-09-24
00085412087672LOW RECIRCULATION VOLUME APD SETN5C8305CN5C8305C2015-09-24
00085412088433AUTOMATED PD SETR5C4479CR5C4479C2015-09-24
00085412090078INTERGRATED APD SETL5C4531L5C45312015-09-24
00085412007021HomeChoice APD System5C44715C44712015-10-23
00085412007038HomeChoice APD System5C4471R5C4471R2015-10-23
00085412026350HomeChoice PRO APD System5C8310R5C8310R2015-10-23
00085412079165HomeChoice PRO APD System5C83105C83102015-10-23
00085412088341V-LINK/VITALSHIELD6N83786N83782016-09-24
00085412088327V-LINK/VITALSHIELD6N83746N83742016-09-24
00085412001036NA2C40312C40312016-09-24
00085412004716INTERLINK2N33332N33332016-09-24
00085412004921INTERLINK2N33762N33762016-09-24
00085412004976INTERLINK2N33952N33952016-09-24
00085412071657CLEARLINK2N83412N83412016-09-24
00085412001029NA2C40302C40302016-09-24
05413760308371Fibrinotherm060004706000472018-09-21
00085412003252N/A2B80662B80662016-09-24
00085412000046INTRAVIA2B80142B80142016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00887709098602ICU Medical, Inc.ICU MEDICAL, INC.NEP2026-05-28
00887709166288ICU Medical, Inc.ICU MEDICAL, INC.NEP2026-04-16
00887709166295ICU Medical, Inc.ICU MEDICAL, INC.NEP2026-04-16
00887709166318ICU Medical, Inc.ICU MEDICAL, INC.NEP2026-04-16
00887709170988ICU Medical, Inc.ICU MEDICAL, INC.NEP2026-04-16
00887709127371ICU Medical, Inc.ICU MEDICAL, INC.NEP2026-04-01
00887709127388ICU Medical, Inc.ICU MEDICAL, INC.NEP2026-04-01
00887709127395ICU Medical, Inc.ICU MEDICAL, INC.NEP2026-04-01
00887709127432ICU Medical, IncICU MEDICAL, INC.NEP2026-04-01
00887709125995ICU Medical, Inc.ICU MEDICAL, INC.NEP2026-01-12
00887709167216ICU Medical, Inc.ICU MEDICAL, INC.NEP2025-10-20
00860001977356OnsetOnpharma CompanyNEP2025-09-19
00085412169286DUO-VENTBaxter Healthcare SANEP2025-03-20
50085412169281DUO-VENTBaxter Healthcare SANEP2025-03-20
00860006285043IVX ManagerOmnicell, Inc.NEP2024-05-10
00840619054908DianaTM Automated Drug Compounding SystemICU MEDICAL, INC.NEP2024-02-20
00840619065058DianaTM Automated Drug Compounding SystemICU MEDICAL, INC.NEP2024-02-20
00840619089894DianaTM Automated Drug Compounding SystemICU MEDICAL, INC.NEP2024-02-20
00840619090876DianaTM Automated Drug Compounding SystemICU MEDICAL, INC.NEP2024-02-20
00840619091590DianaTM Automated Drug Compounding SystemICU MEDICAL, INC.NEP2024-02-20
00850033629408Acta MedicalActa Medical LLCNEP2024-02-14
00860006285036IVX CloudOmnicell, Inc.NEP2024-01-10
08426314948258GRI-FILLLABORATORIOS GRIFOLS SANEP2023-07-19
00887709125117DianaTM Compounding Workflow SystemICU MEDICAL, INC.NEP2023-04-10
00887709125124DianaTM Compounding Workflow SystemICU MEDICAL, INC.NEP2023-04-10
00887709125131DianaTM Compounding Workflow SystemICU MEDICAL, INC.NEP2023-04-10
00887709125735DianaTM Compounding Workflow SystemICU MEDICAL, INC.NEP2023-04-10
00887709126497DianaTM Compounding Workflow SystemICU MEDICAL, INC.NEP2023-04-10
00887709126589DianaTM Compounding Workflow SystemICU MEDICAL, INC.NEP2023-04-10
00887709126596DianaTM Compounding Workflow SystemICU MEDICAL, INC.NEP2023-04-10