FDA.reportPublic FDA data

Monoject

Primary DI
10884521013933
Brand
Monoject
Company
Cardinal Health, Inc.
Model
8881225221
Catalog number
8881225221
Device description
Blood Collection Set with Tube Holder,Attached 12 inch (30.5 cm) Tubing
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FOZCatheter,intravascular,therapeutic,short-term less than 30 days

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 DaysGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20884521013930PackageGS150In Commercial Distribution
10884521013933PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452101393020884521013930
1088452101393310884521013933

GMDN Terms#

Term, Definition table
TermDefinition
Non-fixed blood collection needleA sharp bevel-edged, hollow tubular metal instrument intended to be used as part of a blood collection set for drawing blood from a patient; it does not include wings for fixation/placement (i.e., not a venous butterfly/scalp vein needle). It is intended to be connected to blood collection tubing and/or a blood collection Luer connector for transfer into a blood specimen receptacle. It may include a pre-attached blood collection tube spike and/or a safety cover; however, it does not include blood collection tubing or a tube holder (i.e., not a set). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00;

Regulatory Flags#

DUNS number
080935429
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884521190948Kangaroo384500W384500W2017-09-12
10884521190894Kangaroo3844003844002017-08-02
10884521544475Wings67093670932018-06-27
20884521544489Wings67095670952018-06-27
10884521023284Monoject8507SA8507SA2016-09-24
10884521208742Devon31145892311458922018-06-29
20884521154244Monoject8985PG2Y8985PG2Y2017-01-06
20884521513423Kendall8618RC8618RC2017-05-27
20884521706177Kangaroo388105E388105E2017-04-20
20884527016034Devon31145926311459262018-06-29
30884521022533Monoject8997SPG28997SPG22016-09-24
30884521022557Monoject8998SPG28998SPG22016-09-24
30884527016048Devon31145942311459422018-06-29
40884521022417Monoject8932PG28932PG22016-09-24
10884521019119SharpSafety8556H8556H2018-06-27
20884527000125Argyle888825737888882573782016-09-24
20884527000132Argyle888825738688882573862016-09-24
10884527019854Argyle888850103188885010312016-09-24
10884527019922Argyle888850200588885020052016-09-24
10884527019847Argyle888850102388885010232016-09-24

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Primary DI, Brand, Company table
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