FDA.reportPublic FDA data

Extension Set Regular Bore

Primary DI
00853620005357
Brand
Extension Set Regular Bore
Company
Merit Pharmaceutical
Model
088713723000
Published
2019-01-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K162601000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162601000Infusion Set for Single UseShinva Ande Healthcare Apparatus Co., Ltd.2017-05-31FPA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10853620005354PackageGS150In Commercial Distribution
20853620005351PackageGS14In Commercial Distribution
00853620005357PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085362000535410853620005354
2085362000535120853620005351
00853620005357008536200053578536200053570853620005357

GMDN Terms#

Term, Definition table
TermDefinition
Intravenous administration tubing extension setA collection of tubing and connectors intended to establish an extension of tubing where the standard length of the tubing in an intravenous (IV) administration set is insufficient. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
(323) 227-4831solutions@meritpharm.com

Regulatory Flags#

DUNS number
093370369
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
00853620005401"21G x 3/4 Safety Blood Collection 12"" Tubing"0233362621252019-01-01
00853620005418"23G x 3/4 Safety Blood Collection 12"" Tubing"0244412326872019-01-01
00853620005944Empty IV Bag 1000mL MIVB1000502025-10-13
00853620005173MeritPoint0444533040002019-01-01
00853620005241100cc Syringe0446436865002019-01-01
00853620005388200cc Syringe0446746097502019-01-01
00853620005180IV Catheter0356625880002019-01-01
00853620005227IV Catheter0355998530002019-01-01
008536200052343cc Syringe0445818400002019-01-01
008536200054561cc TB LL Syringe0422207630002019-01-01
0085362000546360cc Syringe0447055330002019-01-01
00853620005203IV Set With In-Line Filter0363195710002019-01-01
00853620005210IV Set0360668440002019-01-01
00853620005272IV Administration Set0360668440002019-01-01
00853620005319IV Administration Set Needlefree0362112740002019-01-01
00853620005326IV Administration Set 15 Drop0360274330002019-01-01
00853620005333IV Administration Set 60 Drop0361062220002019-01-01
00853620005302Pressure Infuser 1000mL0996818425002019-01-01
00853620005296Blood Administration Set0255462032502019-01-01
00853620005289Pressure Infuser0996323650002019-01-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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