FDA.reportPublic FDA data

LiteTouch

Primary DI
10732671105117
Brand
LiteTouch
Company
AMITY HOLDINGS, LLC
Model
511
Device description
"MediCore's ""Litetouch"" Insulin Syringe"
Published
2016-09-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMFSyringe, Piston
FMINeedle, Hypodermic, Single Lumen

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20732671205111PackageGS110Not in Commercial Distribution
30732671305115PackageGS15Not in Commercial Distribution
10732671105117PrimaryGS10
00732671005113Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2073267120511120732671205111
3073267130511530732671305115
1073267110511710732671105117
00732671005113007326710051137326710051130732671005113

GMDN Terms#

Term, Definition table
TermDefinition
Insulin syringe/needle, basicA sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used to administer an injection of insulin to a patient subcutaneously; a non-retractable needle is included, either attached or detached (usually capped for user protection). The syringe is typically made of plastic and silicone materials and will have plunger anti-sticking properties allowing smooth plunger movement. It can be used by healthcare personnel or patient, and will allow for the aspiration of the pharmaceutical from its container for direct administration to the patient or via an intravenous (IV) port, heparin lock, or saline lock. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length12.7Millimeter
Needle Gauge28Gauge
Total Volume1Milliliter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800 327 8894wconety@medicore.com

Regulatory Flags#

DUNS number
016069284
Device count
10
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00732671009319PIP9319312019-12-30
00732671009326PIP9329322019-12-30
00732671009418Pip9419412021-06-21
10732671209426Pip9429422021-06-21
00732671109422Pip 942-2942-22021-06-21
30732671309403Pip940-50940-502026-04-16
00732671009401Pip9409402021-06-21
00732671009425Pip 942-1942-12021-06-21
10732671109023Pip9029022020-08-27
10732671109030PIP9039032020-08-27
10732671105315LiteTouch5312016-09-01
10732671105322LiteTouch5322016-09-01
10732671105339LiteTouch5332016-09-01
10732671105346LiteTouch5342016-09-01
10732671105353LiteTouch5352016-09-01
10732671106176LiteTouch6172016-09-01
10732671106183LiteTouch6182016-09-01
00732671021182LiteTouch211821182021-12-21
00732671022110LiteTouch 221122112021-06-21
00732671022127LiteTouch221222122021-06-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450486955Merit Medical®Merit Medical Systems, Inc.FMF2026-07-25
10816336022275NC600300-ENFNEOCHILD, LLCFMF2026-07-23
10816336022282NC602000-ENFNEOCHILD, LLCFMF2026-07-23
10816336022442NC600100-ENFNEOCHILD, LLCFMF2026-07-23
00884450492888Merit Medical®Merit Medical Systems, Inc.FMF2026-07-22
10383017593015Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017593213Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017593411Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017593510Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017593718Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017844612Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017844711Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017844919Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
18257200121076O-GENESISOrthofix US LLCFMF2026-07-17
18257200121083O-GENESISOrthofix US LLCFMF2026-07-17
10192253005127MonojectCardinal Health 200, LLCFMI2026-07-13
10192253005509MonojectCardinal Health 200, LLCFMI2026-07-13
00810011730809huahongTianjin Huahong Technology Co., Ltd.FMI2026-07-10
00810011730816QikDiagTianjin Huahong Technology Co., Ltd.FMI2026-07-10
16972857297784Easydrip Glider5 Classic Pro Pen NeedlesSandstone Medical (Suzhou) Inc.FMI2026-07-09
16972857297791Easydrip PentaGlider Plus Pro Pen NeedlesSandstone Medical (Suzhou) Inc.FMI2026-07-09
20192253036982MonojectCardinal Health 200, LLCFMI2026-07-09
20192253036999MonojectCardinal Health 200, LLCFMI2026-07-09
20192253037026MonojectCardinal Health 200, LLCFMI2026-07-09
20192253037033MonojectCardinal Health 200, LLCFMI2026-07-09
20192253037040MonojectCardinal Health 200, LLCFMI2026-07-09
20192253037064MonojectCardinal Health 200, LLCFMI2026-07-09
20192253037071MonojectCardinal Health 200, LLCFMI2026-07-09
20192253037088MonojectCardinal Health 200, LLCFMI2026-07-09
20192253037101MonojectCardinal Health 200, LLCFMI2026-07-09