FDA.reportPublic FDA data

Biomedix B12 SELEC-3+NIS IV ADM. SET

Primary DI
00851470007026
Brand
Biomedix B12 SELEC-3+NIS IV ADM. SET
Company
BIOMEDIX-INC
Model
B12-102
Device description
B12 SELEC-3+NIS IV ADM. SET
Published
2016-09-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
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
K142097000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142097000SELEC-3 I.V.ADMINISTRATION SETBiomedix, Inc.2014-08-29FPA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851470007026PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851470007026008514700070268514700070260851470007026

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.

Sterilization Methods#

Method table
Method
Radiation Sterilization

Regulatory Flags#

DUNS number
798045530
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Contains natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851470007002Biomedix B10 SELEC-3 IV ADM. SETB10-1022016-09-19
00851470007019Biomedix B11 SELEC-3+SC IV ADM. SETB11-1022016-09-19
00851470007033Biomedix B15 SELEC-3+SC+NIS IV ADM. SETB15-1022016-09-19
00851470007040Biomedix B30 SELEC-3+NIS+LAS IV ADM. SETB30-1022016-09-19
00851470007057Biomedix B31 SELEC-3+NIS+LAS IV ADM. SETB31-1022016-09-19
00851470007064Biomedix B32 SELEC-3+NIS+LAS IV ADM. SETB32-1022016-09-19
00851470007071Biomedix B36 SELEC-3+LAS IV ADM. SETB36-1022016-09-19
00851470007088Biomedix B37 SELEC-3+NIS+LAS IV ADM. SETB37-1022016-09-19
00851470007095Biomedix B38 SELEC-3+NIS+LAS IV ADM. SETB38-1022016-09-19
00851470007101Biomedix B39 SELEC-3+SC+LAS IV ADM. SETB39-1022016-09-19
00851470007118Biomedix B62 SELEC-3+NIS+LAS IV ADM. SETB62-1022016-09-19
00851470007125Biomedix B72 SELEC-3+NIS+LAS IV ADM. SETB72-1022016-09-19
00851470007132Biomedix B74 SELEC-3+NIS+LAS IV ADM. SETB74-1022016-09-19
00851470007149Biomedix B76 SELEC-3+LAS IV ADM. SETB76-1022016-09-19
00851470007156Biomedix B95 SELEC-3+NIS IV ADM. SETB95-1022016-09-19

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Primary DI, Brand, Company table
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18859299138326ADRx Admixture SystemEPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDLHI2026-08-01
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