FDA.reportPublic FDA data

Verisafe

Primary DI
06975965299407
Brand
Verisafe
Company
Promisemed Medical Devices Inc.
Model
RBC-2330S(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
16975965299404PackageGS18In Commercial Distribution
06975965299407PrimaryGS10
86975965299403Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697596529940416975965299404
06975965299407069759652994076975965299407
8697596529940386975965299403

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
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
06975965299360VerisafeRBC-2319A(S)2026-01-19
06975965299377VerisafeRBC-2319S(S)2026-01-19
06975965299384VerisafeRBC-2319H(S)2026-01-19

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00814965020788Precision PointGold Coast Medical Supply, LPFMI2026-08-26
06972857295677contour comfort Pen NeedleSandstone Medical (Suzhou) Inc.FMI2026-08-19
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