FDA.reportPublic FDA data

B.I.G.

Primary DI
07290008325042
Brand
B.I.G.
Company
WaisMed Ltd
Model
B.I.G.- P
Device description
The Pediatric B.I.G. device is indicated to provide intraosseous access into the proximal tibia on children from 0-12 years of age.
Published
2017-02-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

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
K022415000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K022415000BONE INJECTION GUN (B.I.G.) FOR PEDIATRICS, MODEL 1STWaismed, Ltd.2002-10-11FMI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17290008325049PackageGS112In Commercial Distribution
07290008325042PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1729000832504917290008325049
07290008325042072900083250427290008325042

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.

Contacts#

Phone, Email table
PhoneEmail
1-888-737-7978info@ps-med.com

Regulatory Flags#

DUNS number
514619238
Device count
1
Lot or batch
true
Expiration date on label
true

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
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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