FDA.reportPublic FDA data

Magellan

Primary DI
20192253025351
Brand
Magellan
Company
Cardinal Health 200, LLC
Model
8881811310
Catalog number
8881811310
Device description
Syringe with Hypodermic Safety Needle
Published
2021-09-17
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

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
20192253025351PackageGS150In Commercial Distribution
50192253025352PackageGS14In Commercial Distribution
10192253025354PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2019225302535120192253025351
5019225302535250192253025352
1019225302535410192253025354

GMDN Terms#

Term, Definition table
TermDefinition
Metered-delivery hypodermic syringe/needleA sterile device consisting of a graduated barrel (cylinder) with plunger and an attached retractable-needle, intended to be used to deliver an accurate metered dose of a substance (e.g., medicine or drug) during a patient injection. The syringe is typically made of plastic/silicone with an anti-sticking plunger allowing for smooth plunger movement; after use, the plunger is fully retracted into the barrel providing protection against needle sticks, and rendering the device unusable. It may be referred to as a safety syringe and can be used by healthcare personnel or patients. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
961027315
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
10192253047967Kendall92339233-2026-05-26
20192253017615Medi-Trace Cadence22661PC22661PC2021-07-29
20192253019992Kendall33547T33547T--2026-05-26
20885380136617CARDINAL HEALTHN8830N88302019-02-07
20885380136624CARDINAL HEALTHN8831N88312019-02-07
20885380136631CARDINAL HEALTHN8832N88322019-02-07
20885380168069CARDINAL HEALTHC3660PPLC3660PPL2019-04-30
10192253045093KendallMK00175MK001752023-06-15
10192253013016Argyle888875001888887500182022-10-26
10192253013023Argyle888875051388887505132022-10-26
10198956056497CARDINAL HEALTHPN69MSGADPN69MSGAD2026-05-25
10198956057005CARDINAL HEALTHSBACGDPMEDSBACGDPMED2026-05-25
10198956221161CARDINAL HEALTHSOP29PLCCYSOP29PLCCY2026-05-25
10198956253773CARDINAL HEALTHSOP56TKTCCSOP56TKTCC2026-05-25
10198956257610CARDINAL HEALTHSOPOCTKLHKSOPOCTKLHK2026-05-25
10198956258730CARDINAL HEALTHAMN4Q8277CAMN4Q8277C2026-05-25
10198956291812CARDINAL HEALTHSOP4FKPWFBSOP4FKPWFB2026-05-25
10198956300316CARDINAL HEALTH34-2071H34-2071H2026-05-25
10198956321632CARDINAL HEALTHSOPCGKHAUCSOPCGKHAUC2026-05-25
10198956325487CARDINAL HEALTHPO43LEUNCPO43LEUNC2026-05-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850033131208RegenKit®-THT-1-URegenlab USA LLCFMI2026-03-23
40888277358455MEDLINEMEDLINE INDUSTRIES, INC.FMI2026-03-19
40888277358462MEDLINEMEDLINE INDUSTRIES, INC.FMI2026-03-19
10050428324070TRUEplusTRIVIDIA HEALTH, INC.FMI2026-03-17
16923033459243EZFINE THIN WALL HYPODERMIC NEEDLEZhejiang Kindly Medical Devices Co., Ltd.FMI2026-03-10
00850056748568FORWARD® Intraosseous Infusion BundleINTEGRATED MEDCRAFT LLCFMI2026-03-02
10850060997980CerosRhino Medical Supply IncFMI2026-02-23
08800062763736SHARP NEEDLES, DermiSyncYONG CHANG CorporationFMI2026-02-23
10857273002470Clickfine® pen needlesHTL STREFA S AFMI2026-02-17
10857273002487Clickfine® pen needlesHTL STREFA S AFMI2026-02-17
10857273002548Clickfine® pen needlesHTL STREFA S AFMI2026-02-17
10857273002555Clickfine® pen needlesHTL STREFA S AFMI2026-02-17
50192253037119MonojectCardinal Health 200, LLCFMI2026-02-17
20850083784052Comfort EZS.D.I. USA, INC.FMI2026-02-13
20850083784175Comfort EZS.D.I. USA, INC.FMI2026-02-13
04046955143184Omnican® fineB. Braun Melsungen AktiengesellschaftFMI2026-02-10
04046961013068Omnican® fineB. Braun Melsungen AktiengesellschaftFMI2026-02-10
50192253037010MonojectCardinal Health 200, LLCFMI2026-02-10
50192253037058MonojectCardinal Health 200, LLCFMI2026-02-10
50192253037096MonojectCardinal Health 200, LLCFMI2026-02-10
50192253037164MonojectCardinal Health 200, LLCFMI2026-02-10
50192253037171MonojectCardinal Health 200, LLCFMI2026-02-10
50192253037218MonojectCardinal Health 200, LLCFMI2026-02-10
50192253038154MonojectCardinal Health 200, LLCFMI2026-02-10
50192253038161MonojectCardinal Health 200, LLCFMI2026-02-10
50192253038178MonojectCardinal Health 200, LLCFMI2026-02-10
50192253038185MonojectCardinal Health 200, LLCFMI2026-02-10
50192253038192MonojectCardinal Health 200, LLCFMI2026-02-10
50192253038208MonojectCardinal Health 200, LLCFMI2026-02-10
50192253038215MonojectCardinal Health 200, LLCFMI2026-02-10