ONETOUCH MEDICAL, LLC

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3042953454	3042953454	ONETOUCH MEDICAL, LLC	1	Y	2026-01-01	19005 FM 529 RD STE 11A-11B Cypress TX US 77433

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDID	Product	Phone	Email
00850083045425	EasytoUse U-100 Insulin Syringe - 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 0.5 mL (50 unit) capacity and a 27G x 1/2" (12.7mm) fixed needle. Latex-free.	+13465809766	info@onetouchmed.com
00850083045456	EasytoUse U-100 Insulin Syringe - 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 27G x 1/2" (12.7mm) fixed needle. Latex-free.	+1 (346) 580-9766	info@onetouchmed.com
00850083045555	EasytoUse U-100 Insulin Syringe - 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 28G x 1/2" (12.7mm) fixed needle. Latex-free.	+1 (346) 580-9766	info@onetouchmed.com
00850083045623	EasytoUse U-100 Insulin Syringe - 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 0.5 mL (50 unit) capacity and a 29G x 1/2" (12.7mm) fixed needle. Latex-free.	+13465809766	info@onetouchmed.com
00850083045654	EasytoUse U-100 Insulin Syringe - 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 29G x 1/2" (12.7mm) fixed needle. Latex-free.	+1 (346) 580-9766	info@onetouchmed.com
00850083045722	EasytoUse U-100 Insulin Syringe - 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 0.5 mL (50 unit) capacity and a 30G x 5/16" (8mm) fixed needle. Latex-free.	+13465809766	info@onetouchmed.com
00850083045753	EasytoUse U-100 Insulin Syringe - 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 5/16" (8mm) fixed needle. Latex-free.	+1 (346) 580-9766	info@onetouchmed.com
00850083045821	EasytoUse U-100 Insulin Syringe - 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 0.5 mL (50 unit) capacity and a 30G x 1/2" (12.7mm) fixed needle. Latex-free.	+13465809766	info@onetouchmed.com

onetouchmed.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
345938	1810224713	K190002	Sterile Hypodermic Syringe for Single use, with/without needle, Sterile Insulin Syringe for Single use, with needle, Sterile Hypodermic needle for Single use	FMF	2019-09-12

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
FMF	1	2019-09-12

GUDID#

EasytoUse U-100 Insulin Syringe - 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 0.5 mL (50 unit) capacity and a 27G x 1/2" (12.7mm) fixed needle. Latex-free.
OneTouch Medical, LLC
2026-11-03
EasytoUse U-100 Insulin Syringe - 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 27G x 1/2" (12.7mm) fixed needle. Latex-free.
OneTouch Medical, LLC
2026-11-03
EasytoUse U-100 Insulin Syringe - 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 28G x 1/2" (12.7mm) fixed needle. Latex-free.
OneTouch Medical, LLC
2026-11-03
EasytoUse U-100 Insulin Syringe - 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 0.5 mL (50 unit) capacity and a 29G x 1/2" (12.7mm) fixed needle. Latex-free.
OneTouch Medical, LLC
2026-11-03
EasytoUse U-100 Insulin Syringe - 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 29G x 1/2" (12.7mm) fixed needle. Latex-free.
OneTouch Medical, LLC
2026-11-03
EasytoUse U-100 Insulin Syringe - 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 0.5 mL (50 unit) capacity and a 30G x 5/16" (8mm) fixed needle. Latex-free.
OneTouch Medical, LLC
2026-11-03
EasytoUse U-100 Insulin Syringe - 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 5/16" (8mm) fixed needle. Latex-free.
OneTouch Medical, LLC
2026-11-03
EasytoUse U-100 Insulin Syringe - 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 0.5 mL (50 unit) capacity and a 30G x 1/2" (12.7mm) fixed needle. Latex-free.
OneTouch Medical, LLC
2026-11-03
EasytoUse U-100 Insulin Syringe - 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.
OneTouch Medical, LLC
2026-11-03