FDA.reportPublic FDA data

Lingo

Primary DI
30357599848003
Brand
Lingo
Company
ABBOTT DIABETES CARE INC
Model
77263-01
Catalog number
77263-01
Device description
Lingo Glucose Biosensor
Published
2024-07-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
SAFIntegrated continuous glucose monitor for non-intensive glucose monitoring, Over-The-Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
SAFIntegrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-CounterClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30357599848003PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3035759984800330357599848003

GMDN Terms#

Term, Definition table
TermDefinition
Percutaneous interstitial-fluid glucose monitoring system, electrochemicalAn assembly of electrically-powered, portable devices intended to continuously monitor interstitial-fluid glucose concentrations in a patient with diabetes mellitus, using an invasive electrochemical technique. It consists of an electrochemical, percutaneously-inserted electrode that physically connects to a cable or transmitter which communicates with a monitor or receiver (not included) that captures, stores, and converts the sensor signals to glucose concentrations for display. The system may be used in the home and clinical settings, and aids in the detection of episodes of hyperglycaemia and hypoglycaemia, facilitating acute/long-term therapy adjustments.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature36 Degrees Fahrenheit82 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(888)764-7684lingosupport-us@hellolingo.com

Regulatory Flags#

DUNS number
966390890
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00357599835019FreeStyle Libre 2 Plus78747787472025-07-25
00357599836016FreeStyle Libre 2 Plus78749787492025-07-25
00357599880002Instinct78893788932025-09-22
00357599843014FreeStyle Libre 3 Plus78769787692025-07-25
00357599844011FreeStyle Libre 3 Plus78768787682025-07-25
00357599850005Lingo78782-0178782-012025-11-17
00357599820015FreeStyle Libre 372079720792025-07-25
00357599821012FreeStyle Libre 372078720782025-06-25
00357599842017FreeStyle Libre 378754787542025-07-25
00357599833008Abbott78632786322023-01-20
00357599001025FreeStyle Libre 14 day71939719392018-10-10
30357599880003Instinct78893788932025-09-22
00357599803018FreeStyle Libre 271953719532025-07-25
00357599805012FreeStyle Libre 271951719512025-07-25
00357599804015FreeStyle Libre 271952719522025-07-25
30357599805013FreeStyle Libre 271951719512025-07-25
30357599820016FreeStyle Libre 372079720792025-07-25
30357599835010FreeStyle Libre 2 Plus78747787472025-07-25
30357599836017FreeStyle Libre 2 Plus78749787492025-07-25
30357599842018FreeStyle Libre 378754787542025-07-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860013992606Signos Glucose Management SystemSIGNOS, INC.SAF2026-02-24
00357599850005LingoABBOTT DIABETES CARE INCSAF2025-11-17
00386270004857Stelo Glucose Biosensor (2pk)Dexcom, Inc.SAF2025-03-11
00386270004635Dexcom Stelo iOS Mobile AppDexcom, Inc.SAF2024-08-15
00386270004642Dexcom Stelo Android Mobile AppDexcom, Inc.SAF2024-08-15
00386270004659Dexcom Stelo iOS Watch AppDexcom, Inc.SAF2024-08-15
00357599852009LingoABBOTT DIABETES CARE INCSAF2024-07-24
00357599848002LingoABBOTT DIABETES CARE INCSAF2024-07-15
00357599849009LingoABBOTT DIABETES CARE INCSAF2024-07-15
00357599853006LingoABBOTT DIABETES CARE INCSAF2024-07-15
30357599853007LingoABBOTT DIABETES CARE INCSAF2024-07-15
00386270004338Stelo BiosensorDexcom, Inc.SAF2024-03-26
00386270004345Stelo Glucose Biosensor (1pk)Dexcom, Inc.SAF2024-03-26
00386270004383Stelo Glucose Biosensor (2pk)Dexcom, Inc.SAF2024-03-26
00386270004390Stelo Glucose Biosensor (1pk) UPCDexcom, Inc.SAF2024-03-26
00386270004406Stelo Glucose Biosensor (2pk) UPCDexcom, Inc.SAF2024-03-26