FDA.reportPublic FDA data

TwoFer Needle

Primary DI
00853832007071
Brand
TwoFer Needle
Company
MEDSAFETY SOLUTIONS LLC
Model
16004
Catalog number
16004
Device description
TwoFer Huber-Tipped Needle
Published
2017-12-01
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
LHISet, I.V. Fluid Transfer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LHISet, I.V. Fluid TransferGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K832347000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K832347000TWOFER NEEDLEBaxa Corp., Sub. of Cook Group, Inc.1983-09-12LHI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00085412478395PreviousGS10
00853832007071PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00085412478395000854124783950854124783950085412478395
00853832007071008538320070718538320070710853832007071

GMDN Terms#

Term, Definition table
TermDefinition
Medication transfer needle, non-filtering/non-ventedA slender, rigid, sharp or blunt metal tube intended to be attached to a syringe and typically used in the pharmacy to aspirate and transfer fluid medication from a vial/ampule to another container for medication preparation or other purposes. It consists of a short needle sufficient to penetrate the vial stopper and extract all the medication. It is typically of 20 gauge to provide a high-flow rate with minimum coring. It does not include a filter or a back-pressure venting feature. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Needle Gauge16Gauge

Contacts#

Phone, Email table
PhoneEmail
1-720-500-2500info@medsafetysolutions.com

Regulatory Flags#

DUNS number
080521478
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00853832007125KwikDose Oral Dispenser710071002024-12-31
00853832007132KwikDose Oral Dispenser710171012024-12-31
00853832007149KwikDose Oral Dispenser710371032024-12-31
00853832007156KwikDose Oral Dispenser710571052024-12-31
00853832007163KwikDose Oral Dispenser711071102024-12-31
00853832007170KwikDose Oral Dispenser712071202024-12-31
00853832007187KwikDose Oral Dispenser750075002024-12-31
00853832007194KwikDose Oral Dispenser750175012024-12-31
00853832007200KwikDose Oral Dispenser750375032024-12-31
00853832007217KwikDose Oral Dispenser750575052024-12-31
00853832007224KwikDose Oral Dispenser751075102024-12-31
00853832007231KwikDose Oral Dispenser810081002024-12-31
00853832007248KwikDose Oral Dispenser810181012024-12-31
00853832007255KwikDose Oral Dispenser810381032024-12-31
00853832007262KwikDose Oral Dispenser810581052024-12-31
00853832007279KwikDose Oral Dispenser811081102024-12-31
00853832007286KwikDose Oral Dispenser812081202024-12-31
00853832007309KwikDose Oral Dispenser850085002024-12-31
00853832007316KwikDose Oral Dispenser850185012024-12-31
00853832007323KwikDose Oral Dispenser850385032024-12-31

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