FDA.reportPublic FDA data

NA

Primary DI
05413765482595
Brand
NA
Company
BAXTER HEALTHCARE CORPORATION
Model
H93849
Catalog number
H93849
Device description
Admix Dispensing Pin
Published
2016-09-23
Public version status
Update
Distribution status
Not 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
FMFSyringe, piston
LHISet, i.V. Fluid transfer

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K872743000
K900585000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K872743000BAXA TUBING SETS (FOR PHARMACY PUMP)Baxa Corp., Sub. of Cook Group, Inc.1987-10-09FMF
K900585000TUBING SETS FOR BAXA EXACTA-MED PHARMACY PUMPBaxa Corp., Sub. of Cook Group, Inc.1990-04-18LHI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
55413765482590PackageGS150Not in Commercial Distribution
05413765482595PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
5541376548259055413765482590
05413765482595054137654825955413765482595

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.

Contacts#

Phone, Email table
PhoneEmail
+1(800)422-9837cfs_customer_service@baxter.com

Regulatory Flags#

DUNS number
005083209
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
00085412478296BaxterH93813501H938135012026-05-29
00085412478302BaxterH93813601H938136012026-05-29
00085412004945INTERLINK2N33792N33792016-09-24
00085412004983INTERLINK2N33992N33992016-09-24
00085412048895CLEARLINK2N83992N83992016-09-24
00085412002125INTERLINK2C64022C64022016-09-24
00085412003948INTERLINK/DUO-VENT2C64192C64192016-09-24
00085412017716INTERLINK/CONTINU-FLO3C00623C00622016-09-24
00085412046389CLEARLINK/DUO-VENT2C88752C88752016-09-24
00085412048499CLEARLINK/DUO-VENT2H84802H84802016-09-24
00085412048932CLEARLINK2C84012C84012016-09-24
00085412048949CLEARLINK2C84022C84022016-09-24
00085412048987CLEARLINK/CONTINU-FLO2C85462C85462016-09-24
00085412048994CLEARLINK/CONTINU-FLO2C85192C85192016-09-24
00085412049090CLEARLINK2H84012H84012016-09-24
00085412051703CLEARLINK/CONTINU-FLO2C85152C85152016-09-24
00085412068190INTERLINK2H64012H64012016-09-24
00085412069302CLEARLINK/CONTINU-FLO/CONTROL-A-FLO2C88952C88952016-09-24
00085412071107CLEARLINK/CONTINU-FLO/DUO-VENT2C85412C85412016-09-24
00085412071190CLEARLINK2C84252C84252016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05391530753944FD-1017NS - 1ml PC Syringe - White PlungerDMC MEDICAL LIMITEDFMF2026-06-03
05391530753951FD-1018NS - 1ml PC Syringe - Blue PlungerDMC MEDICAL LIMITEDFMF2026-06-03
05391530754217FD-1078NS 20ml PC Syringe - White Plunger - Saline PrintDMC MEDICAL LIMITEDFMF2026-06-03
05391530754620FD-1048NS 10ml PC Syringe Yellow Plunger LidocaineDMC MEDICAL LIMITEDFMF2026-06-03
05391530754699FD-1075NS 10ml PC Syringe Light Blue Plunger XylocaineDMC MEDICAL LIMITEDFMF2026-06-03
05391530754941FD-1180NS 3ml Nugen Syringe Red PlungeDMC MEDICAL LIMITEDFMF2026-06-03
05391530754965FD-1162NS 10ml Nugen Syringe Red PlungerDMC MEDICAL LIMITEDFMF2026-06-03
05391530753968FD-1019NS - 1ml PC Syringe - Yellow PlungerDMC MEDICAL LIMITEDFMF2026-06-02
05391530754088FD-1021NS 3ml PC Syringe White PlungerDMC MEDICAL LIMITEDFMF2026-06-02
05391530754194FD-1034NS 20ml PC Syringe Red PlungerDMC MEDICAL LIMITEDFMF2026-06-02
05391530754224FD-1033NS 20ml PC Syringe - Yellow PlungerDMC MEDICAL LIMITEDFMF2026-06-02
05391530754231FD-1092NS 20ml PC Syringe Heparin Print - Red PlungerDMC MEDICAL LIMITEDFMF2026-06-02
05391530753456FD-1032NS - 20ml PC Syringe Blue PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753463FD-1031NS - 20ml PC Syringe White PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753487FD-1113NS - 10ml PC Syringe Contrast Dark Green PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753517FD-1051NS - 10ml PC Syringe Purple Plunger - Lidocaine PrintDMC MEDICAL LIMITEDFMF2026-06-01
05391530753524FD-1043NS - 10ml PC Syringe - Contrast - Yellow PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753531FD-1107NS - 30ml PC Syringe - Yellow PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753548FD-1026NS - 10ml PC Syringe - White PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753555FD-1158NS - 10ml PC Syringe - Heparin/Saline White PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753562FD-1049NS - 10ml PC Syringe - Lidocaine Print - Red PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753579FD-1029NS - 10ml PC Syringe Red PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753593FD-1054NS - 10ml PC Syringe - Nitro Print - Red PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753609FD-1039NS - 10ml PC Syringe - Heparin Print - Red PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753616FD-1071NS - 10ml PC Syringe - Purple PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753623FD-1028NS - 10ml PC Syringe - Yellow PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753647FD-1072NS - 10ml PC Syringe Dark Green PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753654FD-1030NS - 10ml PC Syringe - Light Green PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753661FD-1042NS - 10ml PC Syringe - Contrast Print - Light Blue PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753678FD-1044NS - 10ml PC Syringe - Contrast Print - Red PlungerDMC MEDICAL LIMITEDFMF2026-06-01