NIO

Primary DI
07290008325073
Brand
NIO
Company
WaisMed Ltd
Model
NIO Adult+
Device description
The NIO+ Adult is a single-use, automatic, spring-loaded, intraosseous sterile device with dual safety features for enhanced patient and caregiver safety.The NIO+ is packed in a rigid, low-profile case and can withstand extreme storage and usage conditions. After deployment, its built-in stabilizer base,in conjunction with a stand-alone NIO+ Fixation dressing, ensures that the needle is firmly secured
Published
2025-08-04
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K211968000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211968000NIO+ AdultWaismed, Ltd.2021-07-22FMI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290008325073PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290008325073072900083250737290008325073

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.

Sterilization Methods#

Method table
Method
Radiation Sterilization

Regulatory Flags#

DUNS number
514619238
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
27290008325015GOIOGOIO2017-04-05

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