FDA.reportPublic FDA data

ARROW

Primary DI
10801902215182
Brand
ARROW
Company
TELEFLEX INCORPORATED
Model
IPN928032
Catalog number
9079T-VC-005
Published
2026-07-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K231924000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231924000EZ-IO Intraosseous Vascular Access SystemTeleflex Medical2023-07-25FMI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20801902215189PackageGS15In Commercial Distribution
10801902215182PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080190221518920801902215189
1080190221518210801902215182

GMDN Terms#

Term, Definition table
TermDefinition
Intraosseous infusion kitA collection of sterile devices designed to perform an intraosseous (IO) infusion (i.e., an infusion directly into the bone's medullary cavity for the purpose of administering emergency medications and other fluids). It typically consists of a needle (possibly of a special design), an inserting handle, a scalpel, an infusion set, swabs and sutures. This device is used as an alternate to the preferred intravenous (IV) route when this cannot be established in a timely manner, typically during cardiac arrest, patients with respiratory failure or in shock, and when peripheral IV infusion is very difficult. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature00
Special Storage Condition, Specify00Store between 15 – 30C (59 – 86F). Avoid freezing and excessive heat above 40C (104F).

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
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
10801902228229ARROWIPNB00820ASK-05503-UPM12026-10-26
10801902228236ARROWIPNB00822ASK-05401-NM2026-10-26
10801902228243ARROWIPNB00823MP-17019-TK2026-10-26
10801902228250ARROWIPNB00825FB-19609-K2026-10-26
10801902228267ARROWIPNB00826WJ-054012026-10-26
10801902228274ARROWIPNB00827ASA-25090-SB2026-10-26
10801902228281ARROWIPNB00828AK-05503-L2026-10-26
14026704936882WECK5442345442342026-10-20
14026704936899WECK5442445442442026-10-20
14026704936905WECK5442545442542026-10-20
14026704936912WECK5442325442322026-10-20
14026704936929WECK5442425442422026-10-20
14026704936936WECK5442525442522026-10-20
14026704936943WECK5442325442322026-10-20
14026704936950WECK5442345442342026-10-20
14026704936967WECK5442425442422026-10-20
14026704936974WECK5442445442442026-10-20
14026704936981WECK5442525442522026-10-20
14026704936998WECK5442545442542026-10-20
30801902124921ARROWIPN037387ASK-04100-AMC-S12026-10-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20357515755043UltiCareULTIMED, INC.FMI2026-10-23
16972857299337Pen Needles ClassicSandstone Medical (Suzhou) Inc.FMI2026-10-11
16972857299290Easydrip Readygard DuoSandstone Medical (Suzhou) Inc.FMI2026-10-09
16972857299306Easydrip ReadygardSandstone Medical (Suzhou) Inc.FMI2026-10-09
16972857299313Easydrip ReadygardSandstone Medical (Suzhou) Inc.FMI2026-10-09
00050428167243TRUEplusTRIVIDIA HEALTH, INC.FMI2026-10-07
00050428167267TRUEplusTRIVIDIA HEALTH, INC.FMI2026-10-07
06958697621821One+Step INSULIN PEN NEEDLEANHUI HONGYU WUZHOU MEDICAL MANUFACTURER CO LTDFMI2026-10-01
M99230402912120LCH3Livaclean HealthCarelife (usa) Inc.FMI2026-09-30
M99230403250120LCH3Livaclean HealthCarelife (usa) Inc.FMI2026-09-30
00850002860733Comfort EZ Pro DuoS.D.I. USA, INC.FMI2026-09-28
10192253005059MonojectCardinal Health 200, LLCFMI2026-09-24
10809160538913HalyardMEDICAL ACTION INDUSTRIES INC.FMI2026-09-24
16972857299252Pen NeedlesSandstone Medical (Suzhou) Inc.FMI2026-09-24
MHC18290272EasyTouchMHC MEDICAL PRODUCTS, LLCFMI2026-09-22
MHC18310472EasyTouchMHC MEDICAL PRODUCTS, LLCFMI2026-09-22
MHC18313672EasyTouchMHC MEDICAL PRODUCTS, LLCFMI2026-09-22
MHC18320872EasyTouchMHC MEDICAL PRODUCTS, LLCFMI2026-09-22
MHC18323672EasyTouchMHC MEDICAL PRODUCTS, LLCFMI2026-09-22
00850091070037CoreCareCorecare Products Inc.FMI2026-09-11
00850091070051CoreCareCorecare Products Inc.FMI2026-09-11
00850091070068CoreCareCorecare Products Inc.FMI2026-09-11
00850091070099CoreCareCorecare Products Inc.FMI2026-09-11
00850091070112CoreCareCorecare Products Inc.FMI2026-09-11
00850091070136CoreCareCorecare Products Inc.FMI2026-09-11
00850091070150CoreCareCorecare Products Inc.FMI2026-09-11
00850091070174CoreCareCorecare Products Inc.FMI2026-09-11
00850091070198CoreCareCorecare Products Inc.FMI2026-09-11
00850091070228CoreCareCorecare Products Inc.FMI2026-09-11
00850091070471CoreCareCorecare Products Inc.FMI2026-09-11