FDA.report

ICU Medical

Primary DI
10840619044289
Brand
ICU Medical
Company
ICU MEDICAL, INC.
Model
42362-11
Catalog number
423620411
Device description
6" Arterial Pressure Tubing
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
10840619044289PackageGS125In Commercial Distribution
00840619044282PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1084061904428910840619044289
00840619044282008406190442828406190442820840619044282

GMDN Terms

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

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
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

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10887709188645BivonaFT26CN40NGF177N2026-03-19
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