FDA.reportPublic FDA data

LifeScan U.S. LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30423018473042301847LifeScan U.S. LLC1Y2026-01-0175 Valley Stream Pkwy Malvern PA US 19355

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 GUDIDProductPhoneEmail
00353885004183OneTouch Ultra Blue - OneTouch Ultra Test Strips Blue for blood glucose testing with: OneTouch Ultra 2, OneTouch UltraMini, OneTouch Ultra, OneTouch UltraSmart, OneTouch Ping and OneTouch UltraLink Meters+1(800)227-8862XX@XX.XX
00353885006231OneTouch Ultra - One Touch Ultra Control Solution+1 8002278862XX@XX.XX
00353885008372OneTouch Ultra2 - OneTouch Ultra2 Blood Glucose Monitoring Meter - Warranty replacement+1(800)227-8862XX@XX.XX
00353885009713OneTouch Ultra Blue - OneTouch Ultra Test Strips Blue for blood glucose testing with: OneTouch Ultra 2, OneTouch UltraMini, OneTouch Ultra, OneTouch UltraSmart, OneTouch Ping and OneTouch UltraLink Meters+1(800)227-8862XX@XX.XX
00353885009720OneTouch Ultra Blue - OneTouch Ultra Test Strips Blue for blood glucose testing with: OneTouch Ultra 2, OneTouch UltraMini, OneTouch Ultra, OneTouch UltraSmart, OneTouch Ping and OneTouch UltraLink Meters+1(800)227-8862XX@XX.XX
00353885994255OneTouch Ultra Blue - OneTouch Ultra Test Strips Blue for blood glucose testing with: OneTouch Ultra 2, OneTouch UltraMini, OneTouch Ultra, OneTouch UltraSmart, OneTouch Ping and OneTouch UltraLink Meters+1(800)227-8862XX@XX.XX

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3455071650514152K103553LIFESCAN ONETOUCH SELECT / ULTRA / VITA GLUCOSE CONTROL SOLUTIONJJX2011-02-10
3455071305542669K072543ONETOUCH SELECT BLOOD GLUCOSE MONITORING SYSTEMNBW2007-10-05
3455071368966846K061118ONETOUCH ULTRAMINI BLOOD GLUCOSE MONITORING SYSTEMNBW2006-05-19
3455071259088815K053529ONETOUCH ULTRA 2 BLOOD GLUCOSE MONITORING SYSTEMNBW2006-01-17
3455072007160175K043197ONETOUCH ULTRA, INDUO AND ULTRASMART BLOOD GLUCOSE MONITORING SYSTEMCGA2005-05-20

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NBW32007-10-05
JJX12011-02-10
CGA12005-05-20

GUDID#