FDA.reportPublic FDA data

Verisafe

Primary DI
06975965299360
Brand
Verisafe
Company
Promisemed Medical Devices Inc.
Model
RBC-2319A(S)
Published
2026-01-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
true

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
K243806000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243806000Safety Winged Blood Collection SetsPromisemed Hangzhou Meditech Co., Ltd.2025-01-10FMI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16975965299367PackageGS18In Commercial Distribution
06975965299360PrimaryGS10
86975965299366Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697596529936716975965299367
06975965299360069759652993606975965299360
8697596529936686975965299366

Regulatory Flags#

DUNS number
114566189
Device count
100
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850062218444VerifineRBC-2119A2026-01-19
00850062218451VerifineRBC-2319A2026-01-19
00850062218468VerifineRBC-2519A2026-01-19
00850062218475VerifineRBC-2119H2026-01-19
00850062218482VerifineRBC-2319H2026-01-19
00850062218499VerifineRBC-2519H2026-01-19
06975965299254VerisafeRBC-2119S(S)2026-01-19
06975965299261VerisafeRBC-2119H(S)2026-01-19
06975965299278VerisafeRBC-2130A(S)2026-01-19
06975965299285VerisafeRBC-2130S(S)2026-01-19
06975965299292VerisafeRBC-2130H(S)2026-01-19
06975965299308VerisafeRBC-2219A(S)2026-01-19
06975965299315VerisafeRBC-2219S(S)2026-01-19
06975965299322VerisafeRBC-2219H(S)2026-01-19
06975965299339VerisafeRBC-2230A(S)2026-01-19
06975965299346VerisafeRBC-2230S(S)2026-01-19
06975965299353VerisafeRBC-2230H(S)2026-01-19
06975965299377VerisafeRBC-2319S(S)2026-01-19
06975965299384VerisafeRBC-2319H(S)2026-01-19
06975965299391VerisafeRBC-2330A(S)2026-01-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
16972857299474PEN TIPSSandstone Medical (Suzhou) Inc.FMI2026-11-04
16972857299481PEN TIPSSandstone Medical (Suzhou) Inc.FMI2026-11-04
16972857299498PEN TIPSSandstone Medical (Suzhou) Inc.FMI2026-11-04
16972857299504PEN TIPSSandstone Medical (Suzhou) Inc.FMI2026-11-04
16972857299511PEN TIPSSandstone Medical (Suzhou) Inc.FMI2026-11-04
16972857299528PEN TIPSSandstone Medical (Suzhou) Inc.FMI2026-11-04
16972857299467PEN TIPSSandstone Medical (Suzhou) Inc.FMI2026-11-03
00613703823106EasyPoint®RETRACTABLE TECHNOLOGIES, INC.FMI2026-11-02
00613703823304EasyPoint®RETRACTABLE TECHNOLOGIES, INC.FMI2026-11-02
00613703823908EasyPoint®RETRACTABLE TECHNOLOGIES, INC.FMI2026-11-02
00613703853103EasyPoint®RETRACTABLE TECHNOLOGIES, INC.FMI2026-11-02
00613703853202EasyPoint®RETRACTABLE TECHNOLOGIES, INC.FMI2026-11-02
00613703853301EasyPoint®RETRACTABLE TECHNOLOGIES, INC.FMI2026-11-02
00613703853400EasyPoint®RETRACTABLE TECHNOLOGIES, INC.FMI2026-11-02
00613703853509EasyPoint®RETRACTABLE TECHNOLOGIES, INC.FMI2026-11-02
00613703853608EasyPoint®RETRACTABLE TECHNOLOGIES, INC.FMI2026-11-02
00613703853707EasyPoint®RETRACTABLE TECHNOLOGIES, INC.FMI2026-11-02
00613703853806EasyPoint®RETRACTABLE TECHNOLOGIES, INC.FMI2026-11-02
00613703853905EasyPoint®RETRACTABLE TECHNOLOGIES, INC.FMI2026-11-02
00840216124264LiteTouchAsp Global, LLCFMI2026-11-02
00840216123793LiteTouchAsp Global, LLCFMI2026-10-30
00840216123823LiteTouchAsp Global, LLCFMI2026-10-30
00840216123847LiteTouchAsp Global, LLCFMI2026-10-30
00840216124288LiteTouchAsp Global, LLCFMI2026-10-30
05413206353712K-Pack IITerumo Europe NVFMI2026-10-28
20357515755043UltiCareULTIMED, INC.FMI2026-10-23
16972857299337Pen Needles ClassicSandstone Medical (Suzhou) Inc.FMI2026-10-11
16972857299290Easydrip Readygard DuoSandstone Medical (Suzhou) Inc.FMI2026-10-09
16972857299306Easydrip ReadygardSandstone Medical (Suzhou) Inc.FMI2026-10-09
16972857299313Easydrip ReadygardSandstone Medical (Suzhou) Inc.FMI2026-10-09