FDA.reportPublic FDA data

GO IO

Primary DI
10850026832119
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
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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 gauze/bandageA wound cover intended to be used as an initial, short-term treatment after injury. It typically consists of a gauze pad (e.g., cotton wool or lint) 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
098121274
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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
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
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
00884450030592Merit Medical®Merit Medical Systems, Inc.OJA2026-06-06
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