FDA.reportPublic FDA data

Verisafe

Primary DI
00850062218727
Brand
Verisafe
Company
Promisemed Medical Devices Inc.
Model
MWS-052912-100
Device description
Verifine Safety Sterile Syringes have two types: Type D and type F. Type D is a Syringe with a detachable needle. Type F is a Syringe with a fixed needle.Verifine Safety Sterile Syringes is a sterile device consisting of a calibrated barrel with plunger and a needle.It is made of plastic, stainless steel and silicone materials.After use, the needle retracts into the barrel by depressing the plunger all of the way within the barrel which minimizes the risk of accidental sharps injury.It can be used by health care personnel. Product is delivered sterile. Sterilization process is validated according to EN ISO 11135. This is a single-use device.
Published
2026-04-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FMFSyringe, Piston

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850062218727PrimaryGS10
08850062218729Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850062218727008500622187278500622187270850062218727
08850062218729088500622187298850062218729

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose syringe, single-useA sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used for injection/withdrawal of fluids/gas (e.g., medication) to/from a medical device or the body (i.e., capable of both); a needle is not included. It is intended for various medical applications and is not dedicated to medication administration. At the distal end of the barrel is a male connector (typically Luer-lock/slip type) for the attachment to a hypodermic needle or an administration set. It is typically made of plastic and silicone materials and may have anti-stick plunger allowing smooth plunger movement, either manually or by a syringe pump. This is a single-use device.

Regulatory Flags#

DUNS number
114566189
Device count
100
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
00810185050147Verifine®ISY-7103108-1002026-05-14
00810185050154Verifine®ISY-7033108-1002026-05-14
00810185050161Verifine®ISY-7053108-1002026-05-14
00850062218345VerifineISY-7052912-1002026-04-28
00850062218413VerifineISY-8103108-1002026-04-28
00850062218420VerifineISY-8053108-1002026-04-28
00850062218437VerifineISY-8033108-1002026-04-28
00850062218703VerifineISY-7103108-1002026-04-28
00850062218710VerifineISY-7053108-1002026-04-28
00850062218741VerifineISY-7103108-1002026-04-28
00850062218758VerifineISY-7053108-1002026-04-28
00850062218765VerifineISY-7103106-1002026-04-28
00850062218772VerisafeMWS-012912-1002026-04-28
00850062218802VerifineIPN-32-062026-04-28
00850062218819VerifineSSC-020L2026-04-28
00850062218833VerifineISY-7103108-1002026-04-28
00850062218840VerifineISY-7053106-1002026-04-28
00850062218888VerifineISY-7103108-1002026-04-28
00850062218895VerifineISY-7053106- 1002026-04-28
00850062218901VerifineISY-7103106- 1002026-04-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
18257200121076O-GENESISOrthofix US LLCFMF2026-07-17
18257200121083O-GENESISOrthofix US LLCFMF2026-07-17
05391530753944Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530753951Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530754217Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530754620Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530754699Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530754941NuGen syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530754965NuGen syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530753968Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-02
05391530754088Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-02
05391530754194Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-02
05391530754224Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-02
05391530754231Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-02
05391530753456Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753463Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753487Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753517Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753524Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753531Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753548Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753555Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753562Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753579Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753593Polycarbonate syringe -DMC MEDICAL LIMITEDFMF2026-06-01
05391530753609Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753616Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753623Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753647Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753654Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01