FDA.reportPublic FDA data

EXEL PSV SET 24GX3/4" with 12" TUBE

Primary DI
10020221267072
Brand
EXEL PSV SET 24GX3/4" with 12" TUBE
Company
Exel International
Model
26707
Catalog number
26707
Device description
EXEL PSV SET 24GX3/4" with 12" TUBE, 50/BX, 500/CS
Published
2023-03-16
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

Product Codes#

Code, Name table
CodeName
FPASet, Administration, Intravascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FPASet, Administration, IntravascularGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10020221267072PackageGS150In Commercial Distribution
20020221267079PackageGS110In Commercial Distribution
00020221267075PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1002022126707210020221267072
2002022126707920020221267079
00020221267075000202212670750202212670750020221267075

GMDN Terms#

Term, Definition table
TermDefinition
Blood collection set, invasiveA collection of devices intended to be used by a healthcare professional, in combination with evacuated blood collection tubes, for the routine collection of multiple blood specimens from a patient, via one venipuncture, for clinical analyses. It consists of a blood collection needle or venous butterfly/scalp vein needle and additional devices that may include tubing, male/female Luer-lock connectors, clamps, and a blood collection tube holder. Blood access is directly through the vein with the needle. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
180572216
Device count
1
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
true
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00020221262674EXEL CURVED TIP SYRINGE26267262672023-03-15
00020221263053EXEL Disposable Syringes26305263052026-02-24
00020221260403EXEL Syringes26040260402016-09-20
00020221260427EXEL Syringes26042260422016-09-20
00020221260434EXEL Syringes26043260432016-09-20
00020221260441EXEL Syringes26044260442016-09-20
00020221260458"EXEL 1ml SYRINGE 26Gx3/8"" L-S"26045260452023-03-15
00020221260489EXEL Syringes26048260482016-09-20
00020221260496EXEL Syringes26049260492016-09-20
00020221260502EXEL Syringes26050260502016-09-20
00020221260519"EXEL 1mL TB 21Gx1""-0-DEAD-SPACE"26051260512023-03-15
00020221260663"EXEL 1ml SYRINGE 25Gx1""-0-DEAD-SPACE"26066260662023-03-15
00020221260670"EXEL 1ml SYRINGE 23Gx1""-0-DEAD-SPACE"26067260672023-03-15
00020221261004EXEL Syringes26100261002016-09-20
00020221261011EXEL Syringes26101261012016-09-20
00020221261028EXEL Syringes26102261022016-09-20
00020221261035EXEL Syringes26103261032016-09-20
00020221261042EXEL Syringes26104261042016-09-20
00020221261059EXEL Syringes26105261052016-09-20
00020221261073EXEL Syringes26107261072016-09-20

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