FDA.reportPublic FDA data

CLEARLINK/CONTINU-FLO

Primary DI
00085412565682
Brand
CLEARLINK/CONTINU-FLO
Company
BAXTER INTERNATIONAL INC.
Model
2R8519
Catalog number
2R8519
Device description
"Non-DEHP CONTINU-FLO Solution Set, 2 Luer Activated Valves, Male Luer Lock Adapter with Retractable Collar, 96"" 2.4m approx., 10 drops/mL approx."
Published
2017-07-11
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
FPASet, administration, intravascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FPASet, Administration, IntravascularGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K180739000
K961225000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180739000Clearlink System Solution SetBaxter Healthcare Corporation2019-05-28FPA
K961225000CONTINUFLO SOLUTION SET/SECONDARY MEDICATION SETBaxter Healthcare Corp1996-06-21FPA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50085412565687PackageGS148In Commercial Distribution
00085412565682PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5008541256568750085412565687
00085412565682000854125656820854125656820085412565682

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(800)933-0303Medinfo_medproducts@baxter.com

Regulatory Flags#

DUNS number
005146311
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
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
00811505030573IvenixFresenius Kabi AGFPA2026-06-02
00382905168031BD Intelliport SystemBECTON, DICKINSON AND COMPANYFPA2024-06-07
00382905168000BD Intelliport SystemBECTON, DICKINSON AND COMPANYFPA2024-06-07
04038917423410Safety-Multifly® 23G w.holderSarstedt Aktiengesellschaft & Co.KGFPA2024-02-20
08436020769177DOSI-FLOWLEVENTON SAUFPA2023-09-08
08436020769184DOSI-FLOWLEVENTON SAUFPA2023-09-08
07613117017422Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017446Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017460Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017484Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017507Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017521Soft-Release-MicroYpsomed AGFPA2020-09-15
08498840009338VYGONVygon CorporationFPA2020-04-21
08498840009895VYGONVygon CorporationFPA2020-04-21
08498840006535VYGONVygon CorporationFPA2020-03-12
04038917423892Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-12-13
04038917423724Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-10-06
04038917423755Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-10-06
04038917423762Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-10-06
04038917423779Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-10-06
04038917423786Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-10-06
04038917423793Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-10-06
04038917423885Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
04038917423915Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
04038917423922Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
04038917423939Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
04038917423960Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
04038917423977Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
04038917423991Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
04038917424004Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30