FDA.reportPublic FDA data

NeedleSafe

Primary DI
00725030550102
Brand
NeedleSafe
Company
INGENIOUS TECHNOLOGIES CORPORATION
Model
II
Device description
NeedleSafe II is a medical safety device that enables single-handed recapping of needles, I.V. catheters and phlebotomy sets. Mounted horizontally or vertically, NeedleSafe II provides vital protection whenever and wherever needed. Examples of service locations include:At every bedsideOn medication cartsInjection traysPhlebotomy traysCritical Care UnitsEndoscopy SuitesPharmacyAnesthesia/SurgeryPathologyEmergency DepartmentPsychiatric wardsNeedleSafe II may be steam autoclaved, gas sterilized, or disinfected by wiping with or soaking in alcohol.
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
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
K936235000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K936235000NEEDLESAFE II & NEEDLEGARD IIIngenious Technologies Corp.1994-03-28FMI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00725030550102PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00725030550102007250305501027250305501020725030550102

GMDN Terms#

Term, Definition table
TermDefinition
Needle recapping device, reusableA device intended to hold a needle cap and allow a user to conveniently recap a needle, providing some user protection against needle sticks. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
941-586-6690slin@ingenious.com

Regulatory Flags#

DUNS number
847274867
Device count
1

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