FDA.report

ICU Medical

Primary DI
10887709060385
Brand
ICU Medical
Company
ICU MEDICAL, INC.
Model
46102-62
Catalog number
46102-62
Device description
Monitoring Kit w/28" Pressure Tubing and Needleless Valve
Published
2021-08-29
Public version status
New
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

Contact Domains

Product Codes

CodeName
DQOCatheter, intravascular, diagnostic

Product Code Classifications

CodeDeviceSpecialtyClass
DQOCatheter, Intravascular, DiagnosticCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10887709060385PackageGS120In Commercial Distribution
00887709060388PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1088770906038510887709060385
00887709060388008877090603888877090603880887709060388

GMDN Terms

TermDefinition
Basic intravenous administration set, noninvasiveA collection of noninvasive devices intended to conduct fluids from an intravenous (IV) administration bag/bottle to a peripheral venous cannula (not included) during gravitational or pump administration to a patient's venous system; some types may in addition be intended for enteral feeding applications. It typically includes tubing, connectors, chambers, and clamps; the bag/bottle may be included. It neither includes devices intended for invasive use nor a heat exchanger. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(866)829-9025customerservice@icumed.com

Regulatory Flags

DUNS number
118380146
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
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

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10887709188720BivonaAT26CS50NSA182N2026-03-24
10887709188737BivonaAT26CS40NSA180N2026-03-24
10887709188744BivonaAT26CS40NSA181N2026-03-24
10887709188751BivonaAT26CS50NSA183N2026-03-24
10887709188836BivonaSU26CN45NGF194N2026-03-24
10887709188843BivonaSU26CN50NGF193N2026-03-24
10887709188850BivonaFT26CN65NSC192N2026-03-24
10887709188874BivonaFT26CN40NGE196N2026-03-24
10887709188881BivonaFT26CN50NSA199N2026-03-24
10887709188904BivonaHF26CS80NSC198N2026-03-24
10887709188805BivonaSU26CN55NGF1902026-03-23
10887709188812BivonaSU26CN60NSC189N2026-03-23
10887709188829BivonaXT26CS70NSC191N2026-03-23

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