FDA.reportPublic FDA data

GOIO

Primary DI
27290008325015
Brand
GOIO
Company
WaisMed Ltd
Model
GOIO
Device description
Intraosseous start kit by PerSys Medical
Published
2017-04-05
Public version status
Update
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
KMKDevice, Intravascular Catheter Securement

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KMKDevice, Intravascular Catheter SecurementGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
27290008325015PackageGS112In Commercial Distribution
17290008325018PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2729000832501527290008325015
1729000832501817290008325018

GMDN Terms#

Term, Definition table
TermDefinition
First aid gauze/bandageA sterile 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 typically used to protect wounds, arrest bleeding, and introduce medications placed on the pad. It is available [non-prescription] over-the-counter (OTC) for use in the home or clinical settings. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
514619238
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
true
Expiration date on label
false
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
07290008325073NIONIO Adult+2025-08-04
17290008325018GOIOGOIO2017-04-05
07290008325097NIO FixationNIO Fixation2020-08-10
17290008325100GOIOGOIO without Fixation2021-04-06
27290008325107GOIOGOIO without Fixation2021-04-06
07290008325080NIONIO-P2020-08-10
07290008325028NIONIO-P2017-02-12
07290008325059NIONIO-A2017-02-12
07290008325066NIONIO-I2019-11-11
07290008325035B.I.G.B.I.G.- A2017-02-12
07290008325042B.I.G.B.I.G.- P2017-02-12
17290008325025NIONIO-P2017-02-12
17290008325032B.I.G.B.I.G.- A2017-02-12
17290008325049B.I.G.B.I.G.- P2017-02-12
17290008325056NIONIO-A2017-02-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850087488303CeeportCEEPORT INC.KMK2026-05-29
00850087488310CeeportCEEPORT INC.KMK2026-05-29
00850087488327CeeportCEEPORT INC.KMK2026-05-29
00850087488334CeeportCEEPORT INC.KMK2026-05-29
00850087488341CeeportCEEPORT INC.KMK2026-05-29
00850087488358CeeportCEEPORT INC.KMK2026-05-29
10618125192585Grip-LokTIDI PRODUCTS, LLCKMK2026-04-15
10816000014070ARROWTELEFLEX INCORPORATEDKMK2025-09-16
10801741082983StatLockBard Access Systems, Inc.KMK2025-05-02
10801741087582StatLockBard Access Systems, Inc.KMK2025-05-02
10816000013868ARROWTELEFLEX INCORPORATEDKMK2025-04-04
10618125192141Grip-LokTIDI PRODUCTS, LLCKMK2024-12-02
10885632416309HalyardOWENS & MINOR DISTRIBUTION, INC.KMK2024-07-30
10885632416279HalyardOWENS & MINOR DISTRIBUTION, INC.KMK2024-07-22
10885632416286HalyardOWENS & MINOR DISTRIBUTION, INC.KMK2024-07-22
10885632416293HalyardOWENS & MINOR DISTRIBUTION, INC.KMK2024-07-22
10618125135148Grip-LokTIDI PRODUCTS, LLCKMK2024-04-22
20653160370694CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKMK2024-03-08
20653160370700CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKMK2024-03-08
20653160370717CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKMK2024-03-08
20653160370724CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKMK2024-03-08
20653160370731CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKMK2024-03-08
20653160370748CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKMK2024-03-08
20653160370755CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKMK2024-03-08
20653160371073CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKMK2024-02-02
20653160369322MEDLINEMEDLINE INDUSTRIES, INC.KMK2023-12-01
10686004000023UltraDressingI.V. House, Inc.KMK2023-07-21
10686004000030UtraDressingI.V. House, Inc.KMK2023-07-21
10686004000054UltraDressingI.V. House, Inc.KMK2023-07-21
10686004000320UltraDomeI.V. House, Inc.KMK2023-07-21