FDA.reportPublic FDA data

B-Smart

Primary DI
18053676290014
Brand
B-Smart
Company
HMC PREMEDICAL SPA
Model
BS015-30
Device description
B-Smart nerve-block injection pressure manometer
Published
2016-10-04
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
CAZAnesthesia Conduction Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CAZAnesthesia Conduction KitAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K031128000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K031128000B-SMART, MODEL B-01Macosta Medical USA, LLC2004-01-15CAZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
38053676290018PackageGS125In Commercial Distribution
58053676290012PackageGS111In Commercial Distribution
18053676290014PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3805367629001838053676290018
5805367629001258053676290012
1805367629001418053676290014

GMDN Terms#

Term, Definition table
TermDefinition
Nerve-block injection manometerA sterile, noninvasive, non-powered (passive) device intended to be connected between a syringe and a nerve-block needle (e.g., fitted to anaesthesia delivery tubing) to indicate injection pressure during administration of local or regional anaesthesia to achieve peripheral nerve blockade. It is intended to provide qualitative feedback (e.g., via a traffic light indicator) to the healthcare professional so that corrective measures can be taken for undesirable pressures (e.g., high injection pressure may indicate undesirable needle tip placement). This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
781.871.7882info@concertmedical.com

Regulatory Flags#

DUNS number
429151652
Device count
1
Lot or batch
true
Expiration date on label
true

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Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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08056814676230DIMAR700/7316US700/7316US2025-03-20
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28056814676258DIMAR700/7318US700/7318US2025-03-20
28056814676265DIMAR700/7319US700/7319US2025-03-20
08056814676360DIMAR700/7309US700/7309US2025-03-20
28056814676371DIMAR700/7310US700/7310US2025-03-20
28056814676388DIMAR700/7311US700/7311US2025-03-20
28056814676395DIMAR700/7312US700/7312US2025-03-20
28056814676401DIMAR700/7313US700/7313US2025-03-20

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