Set, Administration, Intravascular

Primary DI
00858641006208
Brand
Set, Administration, Intravascular
Company
LIFE SCIENCE OUTSOURCING, INC.
Model
EB-060-26
Published
2017-03-29
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FDAEnteroscope And Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FDAEnteroscope And AccessoriesGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K982587000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K982587000MPS FIXED FLOW RATE SETMedical Product Specialists1998-08-24FPA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00858641006208PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858641006208008586410062088586410062080858641006208

GMDN Terms#

Term, Definition table
TermDefinition
Medication transfer setA collection of sterile devices and supplies designed to transfer parenteral medications, and sometimes intravenous (IV) fluids, between a first container(s) [e.g., a vial(s)] and a second container [e.g., an intravenous (IV) bag]; it may also be used to reconstitute medication for its preparation and administration. It is available in a variety of configurations and typically includes tubes, connectors, spike(s), syringes, and caps. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
017149456
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
00858641006000Set, IV, Fluid Transfer1 Pharm-62016-04-26
00858641006017Set, IV, Fluid Transfer1 Pharm-6FG2016-04-26
00858641006055Set, i.V. Fluid Transfer19MMTP2016-05-03
00858641006086Set, I.V. Fluid Transfer19TPV2016-05-03
00858641006024Syringe, Piston18B2016-04-26
00858641006048Ser, administration, intravascular19CHTP2016-05-03
00858641006079Set, Administration, Intravascular19TP2016-05-03
00858641006093Set, Administration, IntravascularDC-006-012016-05-03
00858641006109Set, Administration, IntravascularDC-012-012016-05-03
00858641006116Set, Administration, IntravascularDD-001-142016-05-03
00858641006130Set, Administration, IntravascularEB-060-022016-05-03
00858641006147Set, Administration, IntravascularEI-060-202016-05-03
00858641006154Set, Administration, IntravascularFL1000-FM2016-05-03
00858641006161Set, Administration, IntravascularFL1002-FM2016-05-03
00858641006178Set, Administration, IntravascularFS-175B2016-05-03
00858641006185Set, Administration, IntravascularSM-0132016-05-03
00858641006192Set, Administration, IntravascularSM-0162016-05-03
00858641006031Needle, hypodermic, single lumen19B2016-05-03
00858641006062Set, Administration, Intravascular19MPT2016-05-05
00085641006123Syringe, PistonDD-001-252016-05-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860014745003FUJIFILM Stiffening Wire (SW-2000)Fujifilm Healthcare Americas CorporationFDA2025-12-18
04547410491715FUJIFILMFUJIFILM CORPORATIONFDA2024-07-05
04547410514056FUJIFILMFUJIFILM CORPORATIONFDA2024-07-05
14547410491712FUJIFILMFUJIFILM CORPORATIONFDA2024-07-05
14547410514053FUJIFILMFUJIFILM CORPORATIONFDA2024-07-05
10197106523643CARDINAL HEALTHCardinal Health 200, LLCFDA2024-01-24
50197106523641CARDINAL HEALTHCardinal Health 200, LLCFDA2024-01-24
10197106447185CARDINAL HEALTHCardinal Health 200, LLCFDA2023-11-09
50197106447183CARDINAL HEALTHCardinal Health 200, LLCFDA2023-11-09
10860006600805AncoraAspero Medical, Inc.FDA2023-10-26
00847627004703CD138 + Cyclin D1BIOCARE MEDICAL LLCFDA2023-06-21
04547410467284FUJIFILMFUJIFILM CORPORATIONFDA2023-02-06
04547410324280FUJIFILMFUJIFILM CORPORATIONFDA2023-02-06
04547410467260FUJIFILMFUJIFILM CORPORATIONFDA2023-02-06
14547410467281FUJIFILMFUJIFILM CORPORATIONFDA2023-02-06
04547410463439FUJIFILMFUJIFILM CORPORATIONFDA2022-01-30
04953170165801HANGER ADAPTER SETOLYMPUS MEDICAL SYSTEMS CORP.FDA2021-12-17
04953170165825PROBE ARM SET AOLYMPUS MEDICAL SYSTEMS CORP.FDA2021-12-17
04953170165849PROBE ARM SET BOLYMPUS MEDICAL SYSTEMS CORP.FDA2021-12-17
04953170165740STOPPEROLYMPUS MEDICAL SYSTEMS CORP.FDA2021-12-16
04953170165757WATER RESISTANT CAPOLYMPUS MEDICAL SYSTEMS CORP.FDA2021-12-16
04953170165764PROBE HANGEROLYMPUS MEDICAL SYSTEMS CORP.FDA2021-12-16
06934955960246Jade PTA Balloon Dilatation CatheterOrbusNeich Medical (ShenZhen) Co., Ltd.FDA2020-12-25
00052569143735HealthMart STRATEGIC SOURCING SERVICES LLCFDA2020-07-31
10052569143732HealthMart MCKESSON CORPORATIONFDA2020-07-31
00075289122811ProWorksTRANZONIC COMPANIES, THEFDA2020-04-02
70075289122810ProWorksTRANZONIC COMPANIES, THEFDA2020-04-02
04547410384536FUJIFILMFUJIFILM CORPORATIONFDA2019-07-04
00811503033316Q UROLOGICAL PERSISTENT AGUAMEDICINA Q UROLOGICAL CORPORATIONFDA2019-03-27
10811503033306Q UROLOGICAL PERSISTENT AGUAMEDICINA Q UROLOGICAL CORPORATIONFDA2019-03-27