FDA.reportPublic FDA data

T.A.L.O.N. 7-Site I.O. Starter Kit

Primary DI
M68980081030
Brand
T.A.L.O.N. 7-Site I.O. Starter Kit
Company
Safeguard US Operating, LLC
Model
03
Catalog number
80-081
Device description
T.A.L.O.N. 7-Site I.O. Starter SetT.A.L.O.N. IO Needle Set 1 eaEZ-Stabilizer 1 eaSaline Flush (5cc pre-filled syringe) 1 eaPovidone Prep Pad 2 eaAlcohol Prep Pad 2 eaT.A.L.O.N. IFU 1 eaEZ-Stabilizer IFU 1 ea
Published
2020-04-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

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
M68980081030PrimaryHIBCC0

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, Specify00Store in a cool dry place

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
855-428-6074fulfillment@combatmedicalsystems.com

Regulatory Flags#

DUNS number
118492643
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

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