FDA.reportPublic FDA data

ARROW

Primary DI
30816000013794
Brand
ARROW
Company
TELEFLEX INCORPORATED
Model
IPN915665
Catalog number
9040
Device description
N/A
Published
2020-11-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

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
20816000013797Direct MarkingGS10
30816000013794PackageGS125In Commercial Distribution
10816000013790PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2081600001379720816000013797
3081600001379430816000013794
1081600001379010816000013790

GMDN Terms#

Term, Definition table
TermDefinition
Intraosseous-access handpiece, infusion, electricA hand-held, battery-powered device designed to be used with a separate rotary cutting needle (endpiece) to access bone marrow for intraosseous infusion of fluids and medication. It is used as an alternative to intravenous (IV) access typically when IV access is not feasible. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store between 15 - 30C (59 - 86F).
Storage Environment Temperature-20 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method
High-level Disinfectant

Contacts#

Phone, Email table
PhoneEmail
+1(919)544-8000CS@TELEFLEX.COM

Regulatory Flags#

DUNS number
002348191
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20801902219385ARROWEDC-00622EDC-006222026-03-24
30801902219405ARROWEDC-00820EDC-008202026-03-24
20801902219415ARROWEDC-00822EDC-008222026-03-24
20801902219460ARROWEDC-00818-MEDC-00818-M2026-03-24
20801902219484ARROWEDC-00622-HCEDC-00622-HC2026-03-24
20801902219514ARROWEDC-00822-HCEDC-00822-HC2026-03-24
20801902193418ARROWIPN920120AW-04432-N2026-03-23
30841156103983SUPERCROSS530253022026-03-23
20841156103993SUPERCROSS530353032026-03-23
20841156104006SUPERCROSS530453042026-03-23
20841156104013SUPERCROSS530553052026-03-23
20841156104020SUPERCROSS530653062026-03-23
20841156104037SUPERCROSS530753072026-03-23
20841156104044SUPERCROSS530853082026-03-23
30841156104058SUPERCROSS530953092026-03-23
24026704941494PILLINGP12797P127972026-03-23
24026704941500PILLINGP12805P128052026-03-23
24026704941555PILLINGP13063P130632026-03-23
24026704941562PILLINGP13065P130652026-03-23
24026704941579PILLINGP13081P130812026-03-23

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