FDA.reportPublic FDA data

LiteTouch

Primary DI
00840216124462
Brand
LiteTouch
Company
Asp Global, LLC
Model
2121
Device description
Lite Touch Luer Lock Syringe w/o needle, 10mL
Published
2026-11-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FMFSyringe, Piston

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K132553000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K132553000U&U STERILE PISTON SYRINGE WITHOUT NEEDLEU&U Medical Technology Co, Ltd.2014-02-27FMF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840216124479PackageGS1100In Commercial Distribution
10840216124469PackageGS16In Commercial Distribution
00840216124462PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840216124479008402161244798402161244790840216124479
1084021612446910840216124469
00840216124462008402161244628402161244620840216124462

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume0

Regulatory Flags#

DUNS number
080361159
Device count
1
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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840216123502ReadyLance8022026-11-02
00840216123526ReadyLance8032026-11-02
00840216123557ReadyLance8042026-11-02
00840216123571ReadyLance8052026-11-02
00840216123595ReadyLance8062026-11-02
00840216123861ReadyLance8072026-11-02
00840216123885ReadyLance8082026-11-02
00840216124042MediHeel20032026-11-02
00840216124158MediHeel10032026-11-02
00840216124264LiteTouch5332026-11-02
00840216124387LiteTouch21122026-11-02
00840216124424LiteTouch21132026-11-02
00840216124448LiteTouch21182026-11-02
00840216123694NovaPlus80212026-10-30
00840216123779LiteTouch5182026-10-30
00840216123793LiteTouch5352026-10-30
00840216123809LiteTouch5142026-10-30
00840216123823LiteTouch5322026-10-30
00840216123847LiteTouch5342026-10-30
00840216123908ReadyLance8162026-10-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840216124387LiteTouchAsp Global, LLCFMF2026-11-02
00840216124424LiteTouchAsp Global, LLCFMF2026-11-02
00840216124448LiteTouchAsp Global, LLCFMF2026-11-02
00840216123779LiteTouchAsp Global, LLCFMF2026-10-30
00840216123809LiteTouchAsp Global, LLCFMF2026-10-30
00840216123960LiteTouchAsp Global, LLCFMF2026-10-30
00840216123984LiteTouchAsp Global, LLCFMF2026-10-30
00840216124004LiteTouchAsp Global, LLCFMF2026-10-30
00840216124028LiteTouchAsp Global, LLCFMF2026-10-30
00840216124301LiteTouchAsp Global, LLCFMF2026-10-30
00840216124363LiteTouchAsp Global, LLCFMF2026-10-30
06934841531291TKMDAnhui Tiankang Medical Technology Co., Ltd.FMF2026-10-23
MHC182332552EasyTouchMHC MEDICAL PRODUCTS, LLCFMF2026-10-21
09347144013062Metier MedicalMETIER MEDICAL LTDFMF2026-10-19
09347144013123Metier MedicalMETIER MEDICAL LTDFMF2026-10-19
09347144015004Metier MedicalMETIER MEDICAL LTDFMF2026-10-12
09347144016186Metier MedicalMETIER MEDICAL LTDFMF2026-10-12
09347144016216Metier MedicalMETIER MEDICAL LTDFMF2026-10-12
00850091070532CoreCareCorecare Products Inc.FMF2026-09-11
00850091070556CoreCareCorecare Products Inc.FMF2026-09-11
00850091070570CoreCareCorecare Products Inc.FMF2026-09-11
00850091070594CoreCareCorecare Products Inc.FMF2026-09-11
00850091070617CoreCareCorecare Products Inc.FMF2026-09-11
00850091070631CoreCareCorecare Products Inc.FMF2026-09-11
00850091070655CoreCareCorecare Products Inc.FMF2026-09-11
00850091070679CoreCareCorecare Products Inc.FMF2026-09-11
10816336022671NC603500-ENFNEOCHILD, LLCFMF2026-09-10
00850091070242CoreCareCorecare Products Inc.FMF2026-09-04
00850091070372CoreCareCorecare Products Inc.FMF2026-09-04
00850091070389CoreCareCorecare Products Inc.FMF2026-09-04