FDA.reportPublic FDA data

FORWARD® Intraosseous Infusion Bundle

Primary DI
00850056748568
Brand
FORWARD® Intraosseous Infusion Bundle
Company
INTEGRATED MEDCRAFT LLC
Model
1011-15019
Device description
The Intaosseous Infusion Bundle contains the typical supplies needed to administer a single or multiple intraosseous infusion procedures in a pre-hospital setting. The kit is sealed in a durable, compact poly bag with tear notches for easy opening. The kit contains items such as I/O needles of various sizes, I/O driver, driver adaptors, stabilizer dressings, and I.V. administration sets.
Published
2026-03-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
00850056748568PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850056748568008500567485688500567485680850056748568

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
107523667
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850056748742Pacific Biomedical4818-325032026-07-31
00850056748735Pacific Biomedical4818-325042026-07-30
00850056748216FORWARD APLS Body GuardXAPLSV3378BG-12026-04-21
00850056748605EMS Chest Tube Insertion Kit, 24Fr4818-328002026-04-14
00850056748551Finger Thoracostomy Kit4818-325022026-03-03
00850056748599FORWARD® Classroom Bleeding Control Kit1011-100202026-03-02
00850056748537"FORWARD Finger Thoracostomy Kit 8"" R-Pean, Bilateral"4818-325082025-10-15
00850056748476FORWARD Finger Thoracostomy Kit - Bilateral4818-325012025-08-22
00850056748377APLS Thermal WrapAPLSV-3378H1-42026-02-16
00850056748360APLS Thermal WrapAPLSV-3378H1-42026-02-16
00850056748292FORWARD APLS Litter GuardLGV-2272-22026-01-15
00850056748391FORWARD APLS Transport with Comfort PlusAPLSV-CP-20722025-12-30
00850056748384FORWARD APLS Transport with Comfort PlusAPLSV-CP-20722025-12-30
00850056748544FORWARD USSS Active Shooter Aid Pack (5-Pack in Duffle)USSS-ASAP-D2025-12-11
00850056748513KINGFISHER Compact Individual First Aid Kit766562025-12-05
00850056748230FORWARD APLS Emergency BlanketAPLSV-5982-EB-22025-11-25
00850056748353FORWARD APLS Thermal GuardAPLSV-3391H/3-22025-11-25
00850056748278FORWARD APLS LIFE GUARDAPLSV-3281H/6-22025-10-07
00850056748315FORWARD APLS Surgery SoakerCPV-2854-12025-11-06
00850056748520"FORWARD EMS Chest Tube Insertion Kit, 28Fr, 8"" Pean"4818-328282025-10-15

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