FDA.reportPublic FDA data

EXEL Multi Sample Blood Collecting Needle

Primary DI
30020221265041
Brand
EXEL Multi Sample Blood Collecting Needle
Company
Exel International
Model
26504
Catalog number
26504
Device description
Blood Collection Needle, 21G X 1 1/2
Published
2016-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FMINeedle, Hypodermic, Single Lumen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMINeedle, Hypodermic, Single LumenGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20020221265044PackageGS110In Commercial Distribution
30020221265041PackageGS16In Commercial Distribution
10020221265047PrimaryGS10
00020221265040Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2002022126504420020221265044
3002022126504130020221265041
1002022126504710020221265047
00020221265040000202212650400202212650400020221265040

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
180572216
Device count
100
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20020221260407EXEL Syringes26040260402016-09-20
20020221260421EXEL Syringes26042260422016-09-20
20020221260438EXEL Syringes26043260432016-09-20
20020221260445EXEL Syringes26044260442016-09-20
20020221260490EXEL Syringes26049260492016-09-20
20020221260506EXEL Syringes26050260502016-09-20
20020221261008EXEL Syringes26100261002016-09-20
20020221261015EXEL Syringes26101261012016-09-20
20020221261022EXEL Syringes26102261022016-09-20
20020221261039EXEL Syringes26103261032016-09-20
20020221261046EXEL Syringes26104261042016-09-20
20020221261053EXEL Syringes26105261052016-09-20
20020221261077EXEL Syringes26107261072016-09-20
20020221261084EXEL Syringes26108261082016-09-20
20020221261091EXEL Syringes26109261092016-09-20
20020221261107EXEL Syringes26110261102016-09-20
20020221261114EXEL Syringes26111261112016-09-20
20020221261121EXEL Syringes26112261122016-09-20
20020221261152EXEL Syringes26115261152016-09-20
20020221261169EXEL Syringes26116261162016-09-20

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