FDA.reportPublic FDA data

SafeFill

Primary DI
00854989006023
Brand
SafeFill
Company
Q. I. Medical, Inc.
Model
Large Vial Adapter
Catalog number
SF200L
Device description
Large Vial Adapter, 1 each, female luer slip outlet, locking flanges
Published
2017-03-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LHISet, I.V. Fluid Transfer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LHISet, I.V. Fluid TransferGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K921031000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K921031000EDGE MEDICAL DISPENSING PINEdgewater Medical Center1992-10-19LHI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00854989006054PackageGS150In Commercial Distribution
00854989006023PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00854989006054008549890060548549890060540854989006054
00854989006023008549890060238549890060230854989006023

GMDN Terms#

Term, Definition table
TermDefinition
Fluid transfer set, general-purposeA collection of sterile devices and supplies designed to transfer several types of medical fluids (e.g., drugs, vaccines, blood, and solutions) between a first container(s) [e.g., a vial(s)] and a second container [e.g., an intravenous (IV) bag]. 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
Ethylene Oxide

Regulatory Flags#

DUNS number
800082950
Device count
1
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00854989006030SafeFillSmall Vial AdapterSF200S2017-03-08
00854989006061SafeFillUniversal Vial AdapterSF1002017-03-09
00854989006078QT MicroContamination Tester, luer lock outletTM60002017-03-10
00854989006108QT MicroContamination Tester, luer slip outletTM61002017-03-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08699443585322FlowArt®ASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETILHI2026-02-13
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10815879021783IV PlusNEXUS MEDICAL, LLCLHI2024-09-27
10815879021745IV PlusNEXUS MEDICAL, LLCLHI2024-09-16
10815879021752IV PlusNEXUS MEDICAL, LLCLHI2024-09-16
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10815879021677 Nexus TKO®NEXUS MEDICAL, LLCLHI2024-04-02
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10612479261973McKessonMCKESSON MEDICAL-SURGICAL INC.LHI2022-02-24
08426314778770GRI-FILL 6 to1 SetLABORATORIOS GRIFOLS SALHI2021-10-25
10815879021394IV PlusNEXUS MEDICAL, LLCLHI2021-02-26
10815879021295IV PlusNEXUS MEDICAL, LLCLHI2021-01-20
10850022888011Vial2Bag Advanced 20mmWest Pharmaceutical Services Az, Inc.LHI2020-12-23
10813153020330CodanCodan US CorporationLHI2017-11-30
10813153020316CodanCodan US CorporationLHI2017-10-31