FDA.reportPublic FDA data

GO IO

Primary DI
00850026832112
Brand
GO IO
Company
EINSTEIN WORKS, LLC
Model
1
Catalog number
GO IO-F
Device description
Intraosseous Start Kit w/ Fixation
Published
2021-06-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
OJAIntravenous Extension Tubing Set

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJAIntravenous Extension Tubing SetGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850026832119PackageGS112In Commercial Distribution
00850026832112PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085002683211910850026832119
00850026832112008500268321128500268321120850026832112

GMDN Terms#

Term, Definition table
TermDefinition
First aid absorbent pad/bandageA wound cover intended to be used as an initial, short-term treatment after injury that consists of an absorbent pad (e.g., gauze, cotton wool, lint, cellulose) that is attached to a roll bandage (e.g., cotton or cotton/viscose). The pad is applied directly to the wound, and the bandage is subsequently wrapped around the pad and secured. The device is intended for use in the home or a clinical setting to protect wounds, arrest bleeding, and introduce medications placed on the pad. This is a single-use device.

Regulatory Flags#

DUNS number
098121274
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850026832105NIO NEXT GENERATION IO12021-03-03
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
00850026832020NIO NEXT GENERATION IO1NIO-I2021-02-26
10850026832027NIO NEXT GENERATION IO1NIO-I2021-02-26
00850026832006NIO Next Generation IO1NIO-P2021-02-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450485651Merit Medical®Merit Medical Systems, Inc.OJA2026-06-03
00884450431009Merit Medical®Merit Medical Systems, Inc.OJA2026-06-02
00884450031131Merit Medical®Merit Medical Systems, Inc.OJA2026-05-28
00884450029961Merit Medical®Merit Medical Systems, Inc.OJA2026-04-29
08500835120079Start of Care Kit-SubqOptum Distribution Center, LLCOJA2026-04-28
00884450028247Merit Medical®Merit Medical Systems, Inc.OJA2026-04-28
08500835120048Peripheral IV Start KitOptum Distribution Center, LLCOJA2026-04-27
08500835120062PICC Dressing Change KitOptum Distribution Center, LLCOJA2026-04-27
08500835120055PICC Start of Care KitOptum Distribution Center, LLCOJA2026-04-24
08500835120031Infusion Site Change KitOptum Distribution Center, LLCOJA2026-04-22
00884450028254Merit Medical®Merit Medical Systems, Inc.OJA2026-04-21
00860014354809Arpovo HealthARPOVO, LLCOJA2026-04-20
00860014354816Arpovo HealthARPOVO, LLCOJA2026-04-20
00884450029022Merit Medical®Merit Medical Systems, Inc.OJA2026-04-16
00884450025291Merit Medical®Merit Medical Systems, Inc.OJA2026-04-10
00884450027257Merit Medical®Merit Medical Systems, Inc.OJA2026-04-02
00884450028094Merit Medical®Merit Medical Systems, Inc.OJA2026-04-02
00884450031223Merit Medical®Merit Medical Systems, Inc.OJA2026-03-26
00884450029367Merit Medical®Merit Medical Systems, Inc.OJA2026-03-24
00884450027332Merit Medical®Merit Medical Systems, Inc.OJA2026-03-20
00884450031230Merit Medical®Merit Medical Systems, Inc.OJA2026-03-19
00884450029206Merit Medical®Merit Medical Systems, Inc.OJA2026-03-13
00884450029664Merit Medical®Merit Medical Systems, Inc.OJA2026-03-12
00884450029268Merit Medical®Merit Medical Systems, Inc.OJA2026-03-03
00884450029800Merit Medical®Merit Medical Systems, Inc.OJA2026-02-28
00884450028162Merit Medical®Merit Medical Systems, Inc.OJA2026-02-18
00884450027387Merit Medical®Merit Medical Systems, Inc.OJA2026-02-14
00884450029015Merit Medical®Merit Medical Systems, Inc.OJA2026-02-14
00884450031186Merit Medical®Merit Medical Systems, Inc.OJA2026-02-05
00884450027189Merit Medical®Merit Medical Systems, Inc.OJA2026-01-30