FDA.reportPublic FDA data

TEVADAPTOR® Secondary IV Administration Set with ULTRASITE® Inj. Site

Primary DI
27298119121205
Brand
TEVADAPTOR® Secondary IV Administration Set with ULTRASITE® Inj. Site
Company
TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Model
MG412120
Catalog number
MG412120
Device description
TEVADAPTOR® Secondary IV Administration Set with ULTRASITE® Injection Site for use with OnGuardTM contained Medication System
Published
2016-09-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

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
K121269000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121269000TBAMigada Plant2013-01-22FPA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
27298119121205PrimaryGS10
07298119121201Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2729811912120527298119121205
07298119121201072981191212017298119121201

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
600029649
Device count
70
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
27298119121151TEVADAPTOR® Connecting Set with ULTRASITE® Injection SiteMG412115MG412115 2016-09-15
27298119121168TEVADAPTOR® Spike Port Adaptor Set with ULTRASITE® Injection SiteMG412116MG4121162016-09-15
17298119121116TEVADAPTOR® Vial Adaptor MG412111MG4121112016-09-15
17298119121147TEVADAPTOR® Luer Lock AdaptorMG412114MG4121142016-09-15
17298119121185TEVADAPTOR® Syringe Adaptor MG412118MG4121182016-09-15
17298119121192TEVADAPTOR® 28mm Vial AdaptorMG412119MG4121192016-09-15
27298119121113TEVADAPTOR® Vial Adaptor MG412111 MG412111 2016-09-15
27298119121144TEVADAPTOR® Luer Lock AdaptorMG412114 MG412114 2016-09-15
27298119121182TEVADAPTOR® Syringe Adaptor MG412118 MG412118 2016-09-15
27298119121199TEVADAPTOR® 28mm Vial AdaptorMG412119 MG412119 2016-09-15
27298119121120TEVADAPTOR® Connecting SetMG412112MG4121122016-09-15
27298119121137TEVADAPTOR® Spike Port AdaptorMG412113MG4121132016-09-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04046964716263IV Administration SetB. BRAUN MEDICAL INC.FPA2026-11-02
10885403533822BD Alaris Pump Infusion SetBD Switzerland SàrlFPA2026-10-23
00850017421585twiistSEQUEL MED TECH, LLCFPA2026-10-19
10885403520631BD Alaris Pump Infusion SetBD Switzerland SàrlFPA2026-10-09
10885403533839BD Alaris Pump Infusion SetBD Switzerland SàrlFPA2026-10-09
10885403533846BD Alaris Pump Infusion SetBD Switzerland SàrlFPA2026-10-09
01081633602518WUSA6010NEOCHILD, LLCFPA2026-10-08
10612479285993McKessonMCKESSON MEDICAL-SURGICAL INC.FPA2026-10-06
10612479286013McKessonMCKESSON MEDICAL-SURGICAL INC.FPA2026-10-06
04046955765164IV Administration SetB. BRAUN MEDICAL INC.FPA2026-09-27
00884450707104Merit Medical®Merit Medical Systems, Inc.FPA2026-09-26
00884450707111Merit Medical®Merit Medical Systems, Inc.FPA2026-09-26
04046955114559IV Administration SetB. BRAUN MEDICAL INC.FPA2026-09-19
10850083986008TrueCare BiomedixU.S. Infusion, LLCFPA2026-08-17
10850083986015TrueCare BiomedixU.S. Infusion, LLCFPA2026-08-17
10850083986022TrueCare BiomedixU.S. Infusion, LLCFPA2026-08-17
10850083986039TrueCare BiomedixU.S. Infusion, LLCFPA2026-08-17
10813153027339CodanCodan US CorporationFPA2026-07-31
10813153028312CodanCodan US CorporationFPA2026-07-31
10850048235196HMG Needleless PRN connectorHartman Medical Group LLCFPA2026-07-31
10850048235264HMG IV Administration SetHartman Medical Group LLCFPA2026-07-31
20850048235193HMG Needleless PRN connectorHartman Medical Group LLCFPA2026-07-31
00382903935314NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935321NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935338NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935345NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935352NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935369NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935376NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935383NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30