FDA.reportPublic FDA data

EXEL 1ml SYRINGE 26Gx3/8" L-S

Primary DI
00020221260458
Brand
EXEL 1ml SYRINGE 26Gx3/8" L-S
Company
Exel International
Model
26045
Catalog number
26045
Device description
EXEL Disposable Syringe with Needle, 1mL Luer Slip Tip W/ 26Gx3/8"
Published
2023-03-15
Public version status
Update
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
FMFSyringe, Piston

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10020221260455PackageGS1100In Commercial Distribution
20020221260452PackageGS110In Commercial Distribution
00020221260458PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1002022126045510020221260455
2002022126045220020221260452
00020221260458000202212604580202212604580020221260458

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose syringe/needleA sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used for injection/withdrawal of fluids/gas (e.g., medication) to/from a medical device or the body (i.e., capable of both); a non-retractable needle is included, either attached or detached (usually capped for user protection). It is intended for various medical applications and is not dedicated to medication administration. The syringe is typically made of plastic and silicone materials and may have anti-stick plunger allowing smooth plunger movement, either manually or by a syringe pump. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

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
false
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
00020221012156Tandem Diabetes 3mL LL WITH CO-PACKED NEEDLE 26Gx3/8’’100121510012152023-04-17
00020221012163Tandem Diabetes 5mL LL WITH CO-PACKED NEEDLE 26Gx3/8’’100121610012162023-04-17
000202210605081 mL sterile syringe SNAP26050SNAP26050SNAP2023-04-04
00020221064483EXEL HYPO NDL 28GX3/4" T.W. 2,000/CS, 100PCS/BOX26448B26448B2023-04-06
00020221260175EXEL 0.3mL INS SYR 28GX1/2"26017260172023-03-20
00020221260199EXEL 0.3mL INS SYR 30GX1/2"26019260192023-03-14
00020221260236EXEL 1/2mL INS SYR 28GX1/2"26023260232024-11-25
00020221260243EXEL 1/2mL INS SYR 28GX1/2"26024260242023-03-15
00020221260328EXEL 1/2mL INS 28GX1/2"26032260322023-03-15
00020221260342EXEL 1mL INS 28GX1/2"26034260342023-03-15
00020221260366EXEL U-40 1/2mL INS SYR 29GX1/2"26036260362023-03-15
00020221260373EXEL U-40 1mL INS SYR 29GX1/2"26037260372023-03-15
00020221260380EXEL 1mL AMBER SYR ONLY LUER SLIP W/ TIP CAP26038260382023-03-15
00020221260489EXEL Syringes26048260482016-09-20
00020221260519EXEL 1mL TB 21Gx1"-0-DEAD-SPACE26051260512023-03-15
00020221260564EXEL 1ml Syringe 25Gx1" LDS26056260562023-03-15
00020221260571EXEL 1ml Syringe 23Gx1"26057260572023-03-15
00020221260595EXEL 1mL LDS SYR 20G x 1" LUER LOCK26059260592023-03-15
00020221260601EXEL 1mL ALLERGY SYR 27GX1/2", REGULAR BEVEL26060260602023-03-15
00020221260625EXEL 1mL ALLERGY SYR 28GX1/2"26062260622023-03-15

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Primary DI, Brand, Company table
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