FDA.reportPublic FDA data

NIO NEXT GENERATION IO

Primary DI
00850026832020
Brand
NIO NEXT GENERATION IO
Company
EINSTEIN WORKS, LLC
Model
1
Catalog number
NIO-I
Device description
INFANT NIO INTRAOSSEOUS
Published
2021-02-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850026832027PackageGS112In Commercial Distribution
00850026832020PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085002683202710850026832027
00850026832020008500268320208500268320200850026832020

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.

Regulatory Flags#

DUNS number
098121274
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850026832105NIO NEXT GENERATION IO12021-03-03
00850026832112GO IO1GO IO-F2021-06-24
00850026832044THE EMERGENCY BANDAGE1FCP-092021-02-26
00850026832051THE EMERGENCY BANDAGE1FCP-10T2021-02-26
00850026832068THE EMERGENCY BANDAGE12021-02-26
00850026832075THE EMERGENCY BANDAGE12021-02-26
00850026832082THE EMERGENCY BANDAGE12021-02-26
00860017001281The Emergency BandageBFCP-012020-11-02
00860017001229The Emergency Bandage1FCP-012020-10-02
00860017001236The Emergency Bandage1FCP-022020-10-02
00860017001243The Emergency Bandage1FCP-032020-10-02
00860017001250The Emergency Bandage1FCP-062020-10-02
00860017001267The Emergency Bandage1FCP-T32020-10-02
00860017001274The Emergency Bandage1FCP-09T2020-10-02
00860017001205GO IO12020-09-01
00860017001298THE EMERGENCY ELASTIC WRAP12021-08-16
10850026832119GO IO1GO IO-F2021-06-24
10850026832102NIO NEXT GENERATION IO12021-03-03
10850026832027NIO NEXT GENERATION IO1NIO-I2021-02-26
00850026832006NIO Next Generation IO1NIO-P2021-02-09

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