ICU Medical

Primary DI
10887709048314
Brand
ICU Medical
Company
ICU MEDICAL, INC.
Model
46091-13
Catalog number
460910413
Device description
MONITORING KIT WITH 03ML FLUSH DEVICE FOR CONCORD HOSP.
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
DRSTransducer, blood-pressure, extravascular

Product Code Classifications

CodeDeviceSpecialtyClass
DRSTransducer, Blood-Pressure, ExtravascularCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10887709048314PackageGS110In Commercial Distribution
00887709048317PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1088770904831410887709048314
00887709048317008877090483178877090483170887709048317

GMDN Terms

TermDefinition
Invasive blood pressure transducer setA collection of devices that includes tubing, a pressure transducer(s), and other items [e.g., connectors, stopcock(s), clamps and filters] intended to be used for an invasive blood pressure measurement. This set will typically connect directly to the applied invasive catheter and the transducer will provide the electrical signals for display by a patient monitoring system. This device will have physical characteristics appropriate for preserving, to the extent possible, the waveform and fidelity of the measured pressure. 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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10887709128092ICU Medical, Inc.ICU MEDICAL, INC.DRS2025-04-08
08886483503854ACCUTRANS™ Disposable Pressure Monitoring SystemBIOPTIMAL INTERNATIONAL PTE. LTD.DRS2025-01-22
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00690103201093Acumen IQEdwards Lifesciences LLCDRS2024-08-27
00690103201109ACUMEN IQ SENSOREdwards Lifesciences LLCDRS2024-08-27
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