FDA.reportPublic FDA data

ShippertTech

Primary DI
00850458007058
Brand
ShippertTech
Company
ACTUATED MEDICAL, INC.
Model
IO Needle Safety Sheath
Catalog number
5-IOSS-US
Device description
The IO Needle Safety Sheath (IOSS) is a single-use, non-sterile, anti-needlestick accessory to assist in the removal of intraosseous (IO) needles. IOSS is indicated for use with 25mm and 45mm EZ-IO® Vascular Access Needles and BD Luer-Lok™ 10 mL Syringe.
Published
2023-07-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850458007055PackageGS15In Commercial Distribution
00850458007058PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085045800705510850458007055
00850458007058008504580070588504580070580850458007058

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
791379030
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850458007089TubeClearG-10082017-10-02
00850458007096TubeClearG-10092017-10-02
00850458007102TubeClearG-10102017-10-02
00850458007119TubeClearG-10112017-10-02
00850458007126TubeClearG-10122016-10-27
00850458007140TubeClearG-10142016-10-27
00850458007423TubeClear NE-10422016-10-27
00850458007430TubeClearNE-10432016-10-27
00850458007454TubeClearNE-10452017-10-02
00850458007485TubeClearNE-10482016-10-27
00850458007508TubeClearNE-10502016-10-27
00850458007553TubeClearNE-10552016-10-27
00850458007607TubeClearTC-06082017-03-02
00850458007614TubeClearTC-08122017-03-02
00850458007621TubeClearTC-10182017-10-02
00850458007010TubeClearControl Box Model 101101-US2016-09-08
00850458007362TubeClearNE-10362016-10-27
00850458007195GripTract-GI Endoscopic Tissue ManipulatorGT-GS1002025-12-23
00850458007041GripTract-GI Endoscopic Tissue ManipulatorGT-1012025-01-16
00850458007003TubeClearGJ-1422GJ-14222021-01-01

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