FDA.reportPublic FDA data

CMExpress® Microbore Set with Needleless Y-Site

Primary DI
00818666020139
Brand
CMExpress® Microbore Set with Needleless Y-Site
Company
CME AMERICA LLC
Model
A120-161CYF
Device description
105 in. (267 cm) CMExpress® Microbore Set w/ Needleless Y-Site For Use with the CMExpress® Infusion Pump
Published
2020-07-08
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
FPASet, Administration, Intravascular

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K042696000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K042696000BODYGUARD INFUSION PUMP SYSTEMCaesarea Medical Electronics , Ltd.2005-03-11FRN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00818666020139PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00818666020139008186660201398186660201390818666020139

GMDN Terms#

Term, Definition table
TermDefinition
Electric infusion pump administration set, single-useA collection of sterile devices (e.g., plastic tubing, check valve, roller clamp, Y-site connector, Luer, needle/catheter) intended to be used in combination with an electrically-powered infusion pump for the intravenous (IV), subcutaneous, intramuscular, or epidural administration of medication. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
303-936-4945xx@xx.xx

Regulatory Flags#

DUNS number
002125419
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
B101100100POBSC0T34 Syringe Pump System100-100POBSC2016-09-15
B101100100PSA0T34 Syringe Pump System100-100PSA2016-09-15
B101100105TSA0BodyGuard 121 pump100-105TSA2016-09-15
B101100105TSAR0Refurbished BodyGuard 121 Twins Pump100-105TSAR2016-09-15
B101100908PTS0BodyGuard® 121 Twins Pump100-908PTS2016-09-15
B101100908PTSR0Refurbished BodyGuard® 121 Twins Pump100-908PTSR2016-09-15
B101150317TS0BodyGuard® 121 Pole Mount Charger with DC150-317TS2016-09-16
B101150317TSR0Refurbished BodyGuard® 121 Pole Mount Charger with DC150-317TSR2016-09-16
B101100500PXE0Manufacturing Kit CMExpress® Pump100-500PXE2020-07-08
B101100500PX0CMExpress® Pump100-500PX2016-09-15
B101100500PXA0CMExpress® Pump100-500PXA2016-09-15
B101100500PXR0Refurbished CMExpress® Pump100-500PXR2016-09-15
B101100500XA0CMExpress® Pump100-500XA2016-09-15
B101100500XAR0Refurbished CMExpress® Pump100-500XAR2016-09-15
B101100510PXSI0BG 323 Pump System100-510PXSI2016-09-15
B101100510PXSIR0Refurbished BG 323 Pump System100-510PXSIR2016-09-15
B101100516PXS0BG 323 Pump System100-516PXS2016-09-15
B101100516PXSR0Refurbished BG 323 Pump System100-516PXSR2016-09-15
B101100517PXS0BG 323 Pump System100-517PXS2016-09-15
B101100517PXSR0Refurbished BG 323 Pump System100-517PXSR2016-09-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00827989008243MedSafetyHealth Care Logistics, Inc.FPA2026-07-10
05051684018473LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018480LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018497LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018503LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018510LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018527LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018534LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018541LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018558LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018565LifeguardAngiodynamics, Inc.FPA2026-06-23
05051684018572LifeguardAngiodynamics, Inc.FPA2026-06-23
05051684018589LifeguardAngiodynamics, Inc.FPA2026-06-23
05051684018596LifeguardAngiodynamics, Inc.FPA2026-06-23
05051684018602LifeguardAngiodynamics, Inc.FPA2026-06-23
05051684018619LifeguardAngiodynamics, Inc.FPA2026-06-23
05051684018626LifeguardAngiodynamics, Inc.FPA2026-06-23
05051684018633LifeguardAngiodynamics, Inc.FPA2026-06-23
05051684018640LifeguardAngiodynamics, Inc.FPA2026-06-23
00811505030573IvenixFresenius Kabi AGFPA2026-06-02
04046955836383Infusomat®B. BRAUN MEDICAL INC.FPA2024-08-15
04046955836406Infusomat®B. BRAUN MEDICAL INC.FPA2024-08-15
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
00085412676630DUO-VENTBAXTER HEALTHCARE CORPORATIONFPA2023-07-11
00634624911109Precision Delivery Bifurcated IV Extension SetQUEST MEDICAL INCFPA2022-12-19
00634624911048High-Flow Extension SetQUEST MEDICAL INCFPA2022-12-12
00634624101159Q2 IV Administration SetQUEST MEDICAL INCFPA2022-12-06
00634624101258Q2 IV Administration SetQUEST MEDICAL INCFPA2022-12-06