FDA.reportPublic FDA data

FORWARD IO INFUSION KIT

Primary DI
00850056748018
Brand
FORWARD IO INFUSION KIT
Company
INTEGRATED MEDCRAFT LLC
Model
1011-23000CB
Device description
FORWARD IO Infusion Kit with SAM IO Adaptor, SAM IO Driver, SAM IO 25mm Needle Assembly and SAM IO 45mm Assembly.
Published
2024-01-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K191488000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191488000SAM IO Intraosseous Access SystemSam® Medical Products, Inc.2019-11-21FMI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850056748018PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850056748018008500567480188500567480180850056748018

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
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850056748216FORWARD APLS Body GuardXAPLSV3378BG-12026-04-21
00850056748605EMS Chest Tube Insertion Kit, 24Fr4818-328002026-04-14
00850056748551Finger Thoracostomy Kit4818-325022026-03-03
00850056748568FORWARD® Intraosseous Infusion Bundle1011-150192026-03-02
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
00850056748254FORWARD APLS GURNEY GUARDGG-2272CL2025-10-07

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