FDA.report

Medex

Primary DI
50351688506830
Brand
Medex
Company
ICU MEDICAL, INC.
Model
MX5096020MG
Published
2016-12-29
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

Related Records

Product Codes

CodeName
FPASet, administration, intravascular

Product Code Classifications

CodeDeviceSpecialtyClass
FPASet, Administration, IntravascularGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50351688506830PackageGS125In Commercial Distribution
10351688506832PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
5035168850683050351688506830
1035168850683210351688506832

GMDN Terms

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
Ethylene Oxide

Regulatory Flags

DUNS number
118380146
Device count
1
DM exempt
false
Premarket exempt
true
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
true

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10887709188829BivonaXT26CS70NSC191N2026-03-23
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10887709188768BivonaFU26CN50NGF185N2026-03-22
10887709187921BivonaZT26CN40NGE082N2026-03-19
10887709187938BivonaZU26CN40NGE081N2026-03-19
10887709187945BivonaZT26CN35NGE079N2026-03-19
10887709188645BivonaFT26CN40NGF177N2026-03-19
10887709188652BivonaFT26CN30NGE174N2026-03-19

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