FDA.reportPublic FDA data

Intraosseous Infusion Needles

Primary DI
00840464800026
Brand
Intraosseous Infusion Needles
Company
Ecs Opco 1 LLC
Model
G05986
Catalog number
C-DIN-16-2.5-T45-DKM
Device description
Dieckmann Intraosseous Infusion Needle 45 Degree Trocar - Pediatric Use (Less than 24 months)
Published
2026-05-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
K250724000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250724000Intraosseous Infusion NeedlesSpectrum Vascular2025-07-30FMI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840464800071PackageGS15In Commercial Distribution
00840464800026PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840464800071008404648000718404648000710840464800071
00840464800026008404648000268404648000260840464800026

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
Special Storage Condition, Specify00Specify: Store in dark, dry, cool place.

Regulatory Flags#

DUNS number
119212396
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840464800019Intraosseous Infusion NeedlesG05312C-DIN-14-3.0-T45-DKM2026-05-27
00840464800033Intraosseous Infusion NeedlesG04958C-DIN-16-3.0-T45-DKM2026-05-27
00840464800040Intraosseous Infusion NeedlesG04954C-DIN-16-4.0-T45-DKM2026-05-27
00840464800057Intraosseous Infusion NeedlesG07004C-DIN-18-2.5-T45-DKM2026-05-27
00840464800064Intraosseous Infusion NeedlesG05133C-DIN-18-3.0-T45-DKM2026-05-27

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