FDA.reportPublic FDA data

FORWARD Field Intubation Kit 8.0

Primary DI
00850056748032
Brand
FORWARD Field Intubation Kit 8.0
Company
INTEGRATED MEDCRAFT LLC
Model
1011-40001
Device description
FORWARD Field Intubation Kit 8.0 including Endotracheal Tube and Syringe
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
BTRTube, Tracheal (W/Wo Connector)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTRTube, Tracheal (W/Wo Connector)Anesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K955495000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K955495000RUSCH REINFORCED TRACHAEL TUBE CUFFED, STERILERusch, Inc.1996-06-27BTR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850056748032PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850056748032008500567480328500567480320850056748032

GMDN Terms#

Term, Definition table
TermDefinition
Basic endotracheal tube, single-useA hollow cylinder inserted orally or nasally into the trachea to provide an unobstructed airway to convey gases and vapours to and from the lungs during anaesthesia, resuscitation, and other situations where the patient is not properly ventilated; it does not include an antimicrobial agent(s). The device may: 1) be packaged with a connector that will attach to a breathing circuit or manual resuscitator; 2) have a distal inflatable cuff to seal against the tracheal wall; 3) be radiopaque; and 4) have a built-in pilot balloon for cuff pressure monitoring. It is available in various diameters and lengths for adult and paediatric patients. 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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810003750822KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-08
00810003750839KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-08
00810003750846KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-08
00810003750853ENTRONKENTRON HEALTHCARE, INC.BTR2026-06-08
00810003750860KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-08
00810003750877KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-08
00810003750884KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-08
00810003750891KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-08
00810003750907KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-08
00810003750709KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-07
00810003750716KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-07
00810003750723KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-07
00810003750730KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-07
00810003750747KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-07
00810003750754KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-07
00810003750761KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-07
00810003750778KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-07
00810003750785KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-07
00810003750792KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-07
00810003750808KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-07
00810003750815KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-07
00810003750495KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-01
00810003750501KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-01
00810003750518KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-01
00810003750525KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-01
00810003750532KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-01
00810003750549KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-01
00810003750556KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-01
00810003750563KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-01
00810003750570KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-01