FDA.reportPublic FDA data

Verisafe

Primary DI
06975965299353
Brand
Verisafe
Company
Promisemed Medical Devices Inc.
Model
RBC-2230H(S)
Published
2026-01-19
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
FMINeedle, Hypodermic, Single Lumen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMINeedle, Hypodermic, Single LumenGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16975965299350PackageGS18In Commercial Distribution
06975965299353PrimaryGS10
86975965299359Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697596529935016975965299350
06975965299353069759652993536975965299353
8697596529935986975965299359

GMDN Terms#

Term, Definition table
TermDefinition
Luer-ended blood collection tube spikeA device intended to be used during patient blood collection to facilitate transfer of a clinical blood specimen from blood collection tubing or a needle to a blood specimen receptacle (e.g., evacuated blood collection tube, adapted syringe). It is designed to be fitted to a blood collection tube holder, where it connects to the tubing or needle via a Luer connection at one end, and penetrates an evacuated blood collection tube at the other end for blood collection. This is a single-use device.

Regulatory Flags#

DUNS number
114566189
Device count
50
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Contains 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
00850062218727VerisafeMWS-052912-1002026-04-28
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00810011730816QikDiagTianjin Huahong Technology Co., Ltd.FMI2026-07-10
16972857297784Easydrip Glider5 Classic Pro Pen NeedlesSandstone Medical (Suzhou) Inc.FMI2026-07-09
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20192253036982MonojectCardinal Health 200, LLCFMI2026-07-09
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20192253037026MonojectCardinal Health 200, LLCFMI2026-07-09
20192253037033MonojectCardinal Health 200, LLCFMI2026-07-09
20192253037040MonojectCardinal Health 200, LLCFMI2026-07-09
20192253037064MonojectCardinal Health 200, LLCFMI2026-07-09
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20192253037088MonojectCardinal Health 200, LLCFMI2026-07-09
20192253037101MonojectCardinal Health 200, LLCFMI2026-07-09
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20192253038337MonojectCardinal Health 200, LLCFMI2026-07-09
20192253038368MonojectCardinal Health 200, LLCFMI2026-07-09
00857273002602droplet® pen needlesHTL STREFA S AFMI2026-07-05