FDA.report

ICU Medical

Primary DI
10840619033900
Brand
ICU Medical
Company
ICU MEDICAL, INC.
Model
CH2000S
Device description
Spinning Spiros™, Closed Male Luer
Published
2019-07-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
ONBClosed antineoplastic and hazardous drug reconstitution and transfer system

Product Code Classifications

CodeDeviceSpecialtyClass
ONBClosed Antineoplastic And Hazardous Drug Reconstitution And Transfer SystemGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10840619033900PackageGS1100In Commercial Distribution
00840619033903PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1084061903390010840619033900
00840619033903008406190339038406190339030840619033903

GMDN Terms

TermDefinition
Fluid transfer set, general-purposeA collection of sterile devices and supplies designed to transfer several types of medical fluids (e.g., drugs, vaccines, blood, and solutions) between a first container(s) [e.g., a vial(s)] and a second container [e.g., an intravenous (IV) bag]. It is available in a variety of configurations and typically includes tubes, connectors, spike(s), syringes, and caps. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
118380146
Device count
1
DM exempt
true
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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