FDA.reportPublic FDA data

EasytoUse U-100 Insulin Syringe

Primary DI
00850083045852
Brand
EasytoUse U-100 Insulin Syringe
Company
OneTouch Medical, LLC
Model
IS30101
Device description
Sterile, single-use insulin syringe intended for the manual aspiration of U-100 insulin and subcutaneous injection of insulin into the body. This unit has a 1 mL (100 unit) capacity and a 30G x 1/2" (12.7mm) fixed needle. Latex-free.
Published
2026-11-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
true

Contact Domains#

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
K190002000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190002000Sterile Hypodermic Syringe for Single use, with/without needle, Sterile Insulin Syringe for Single use, with needle, Sterile Hypodermic needle for Single useShanghai Kohope Medical Devices Co., Ltd.2019-09-12FMF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850083045852PrimaryGS10
00850083045845Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850083045852008500830458528500830458520850083045852
00850083045845008500830458458500830458450850083045845

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length0
Needle Gauge0
Total Volume0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
+1 (346) 580-9766info@onetouchmed.com

Regulatory Flags#

DUNS number
847094690
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
false
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850083045425EasytoUse U-100 Insulin SyringeIS270512026-11-03
00850083045456EasytoUse U-100 Insulin SyringeIS271012026-11-03
00850083045555EasytoUse U-100 Insulin SyringeIS281012026-11-03
00850083045623EasytoUse U-100 Insulin SyringeIS290512026-11-03
00850083045654EasytoUse U-100 Insulin SyringeIS291012026-11-03
00850083045722EasytoUse U-100 Insulin SyringeIS300552026-11-03
00850083045753EasytoUse U-100 Insulin SyringeIS301052026-11-03
00850083045821EasytoUse U-100 Insulin SyringeIS300512026-11-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850083045425EasytoUse U-100 Insulin SyringeOneTouch Medical, LLCFMF2026-11-03
00850083045456EasytoUse U-100 Insulin SyringeOneTouch Medical, LLCFMF2026-11-03
00850083045555EasytoUse U-100 Insulin SyringeOneTouch Medical, LLCFMF2026-11-03
00850083045623EasytoUse U-100 Insulin SyringeOneTouch Medical, LLCFMF2026-11-03
00850083045654EasytoUse U-100 Insulin SyringeOneTouch Medical, LLCFMF2026-11-03
00850083045722EasytoUse U-100 Insulin SyringeOneTouch Medical, LLCFMF2026-11-03
00850083045753EasytoUse U-100 Insulin SyringeOneTouch Medical, LLCFMF2026-11-03
00850083045821EasytoUse U-100 Insulin SyringeOneTouch Medical, LLCFMF2026-11-03
00840216124387LiteTouchAsp Global, LLCFMF2026-11-02
00840216124424LiteTouchAsp Global, LLCFMF2026-11-02
00840216124448LiteTouchAsp Global, LLCFMF2026-11-02
00840216124462LiteTouchAsp 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