FDA.reportPublic FDA data

MED-RX

Primary DI
00628725000916
Brand
MED-RX
Company
Canadian Hospital Specialties Limited
Model
10-1302
Catalog number
10-1302
Device description
MED-RX TRANSFER SET, WITH UNIVERSAL SPIKE, PINCH CLAMP
Published
2016-10-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50628725000911PackageGS150In Commercial Distribution
00628725000916PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5062872500091150628725000911
00628725000916006287250009166287250009160628725000916

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

Contacts#

Phone, Email table
PhoneEmail
905-825-9300CHS@CHSLTD.COM

Regulatory Flags#

DUNS number
240992693
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
50628725095078MISI-Medical Imaging Solutions International100301T100301T2025-09-11
50628725095085MISI-Medical Imaging Solutions International1002011002012025-09-11
50628725095108MISI-Medical Imaging Solutions International2001012001012025-09-11
50628725095160MISI-Medical Imaging Solutions International2002012002012025-09-11
50628725095177MISI-Medical Imaging Solutions International200107D200107D2025-09-11
50628725095184MISI-Medical Imaging Solutions International200101i200101i2025-09-11
50628725095191MISI-Medical Imaging Solutions International200301A200301A2025-09-11
50628725095214MISI-Medical Imaging Solutions International200105A200105A2025-09-11
00628725095066MISI-Medical Imaging Solutions International1001011001012025-08-15
50628725095153MISI-Medical Imaging Solutions International400302D400302D2025-08-15
50628725095207MISI-Medical Imaging Solutions International2003012003012025-08-15
50628725095092MISI-Medical Imaging Solutions International100302T100302T2025-08-07
50628725095115MISI-Medical Imaging Solutions International4001084001082025-08-07
50628725095122MISI-Medical Imaging Solutions International400103D400103D2025-08-07
50628725095139MISI-Medical Imaging Solutions International4001014001012025-08-07
00628725095226MISI-Medical Imaging Solutions International100503D100503D2025-08-07
50628725095238MISI-Medical Imaging Solutions International100502D100502D2025-08-07
50628725095245MISI-Medical Imaging Solutions International100501S100501S2025-08-07
50628725095146MISI-Medical Imaging Solutions International4001094001092025-07-07
50628725005374SUTURE REMOVAL KIT852085202025-06-02

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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B21257700R2Luer Lock CapINTERNATIONAL MEDICAL INDUSTRIES INC.FPA2026-01-23
B21257700V2Luer Lock CapINTERNATIONAL MEDICAL INDUSTRIES INC.FPA2026-01-23
B21257700W2Luer Lock CapINTERNATIONAL MEDICAL INDUSTRIES INC.FPA2026-01-23
B21257700Y2Luer Lock CapINTERNATIONAL MEDICAL INDUSTRIES INC.FPA2026-01-23
00813153028179CodanCodan US CorporationFPA2026-01-21
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