FDA.reportPublic FDA data

Decanting Set

Primary DI
20887787006579
Brand
Decanting Set
Company
ICU MEDICAL FLEET SERVICES, LLC
Model
172148
Catalog number
0172148
Device description
LATEX-FREE DECANTING SET, 14 Inch For Aseptic Decanting of Fluid from Rubber Stoppered I.V. Solution Containers (previously Hospira product)
Published
2018-05-31
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
GBXCATHETER, IRRIGATION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GBXCatheter, IrrigationGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20887787006579PackageGS148In Commercial Distribution
10887787006572PrimaryGS10
M33551721480SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088778700657920887787006579
1088778700657210887787006572

GMDN Terms#

Term, Definition table
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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length14Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Room Temperature. Avoid Excessive Heat. Protect from Freezing

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)946-7747uscustomercare@icumed.com

Regulatory Flags#

DUNS number
830767898
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
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20887787003233Plum149548814954882018-05-31
20887787003431Plum197320119732012018-05-31
20887787005015Lifeshield026942802694282016-09-01
20887787006715TUR System65420206542022018-05-31
20887787006722TUR Set65430106543012018-05-31
20887787007248Irrigation Set152390115239012018-05-31
20887787008566Lifeshield192618819261882018-05-31
20887787008764Plum195358819535882018-05-31
20887787009273Primary SetsB917801B9178012018-06-04
20887787009280Primary SetsB920101B9201012018-06-04
20887787009297Primary SetsB947301B9473012018-06-04
20887787009303Primary SetsB912601B9126012018-06-04
20887787006739Irrigation Set65440106544012018-05-31
20887787006746Irrigation Set65990106599012018-05-31
20887787006692Irrigation Set65366506536652018-06-28
20887787006708Irrigation Set65410106541012018-06-28
20887787006494Plum113740511374052016-09-01
20887787003202Lifeshield149518814951882018-05-31
20887787005398Plum125384812538482018-05-31
20887787005725Plum149558814955882018-05-31

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10080196997633MedlineMEDLINE INDUSTRIES, INC.GBX2023-12-27
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08034139292830Thoracic Catheter, Straight Fr 21REDAX SPAGBX2021-05-07
08034139292847Thoracic Catheter, Straight Fr 24REDAX SPAGBX2021-05-07