Tempo Refill Kit MC0002001AM

GUDID 50300021151558

Tempo Refill Kit - This is a convenience kit which contains multiple devices with different counts: Lancets/Strips/BD needles and gauze pads.

ELI LILLY AND COMPANY

Glucose monitoring system IVD, home-use
Primary Device ID50300021151558
NIH Device Record Keycd2d5795-9b78-478d-aef1-e1f5015cc2f4
Commercial Distribution StatusIn Commercial Distribution
Brand NameTempo Refill Kit
Version Model NumberMC0002
Catalog NumberMC0002001AM
Company DUNS006421325
Company NameELI LILLY AND COMPANY
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone1-855-545-5983
Emailxx@xxx.xxx
Phone1-855-545-5983
Emailxx@xxx.xxx
Phone1-855-545-5983
Emailxx@xxx.xxx
Phone1-855-545-5983
Emailxx@xxx.xxx
Phone1-855-545-5983
Emailxx@xxx.xxx
Phone1-855-545-5983
Emailxx@xxx.xxx
Phone1-855-545-5983
Emailxx@xxx.xxx
Phone1-855-545-5983
Emailxx@xxx.xxx
Phone1-855-545-5983
Emailxx@xxx.xxx
Phone1-855-545-5983
Emailxx@xxx.xxx
Phone1-855-545-5983
Emailxx@xxx.xxx
Phone1-855-545-5983
Emailxx@xxx.xxx
Phone1-855-545-5983
Emailxx@xxx.xxx

Operating and Storage Conditions

Storage Environment TemperatureBetween 34 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 34 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 34 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 34 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 34 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 34 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 34 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 34 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 34 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 34 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 34 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 34 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 34 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100300021151553 [Primary]
GS150300021151558 [Package]
Contains: 00300021151553
Package: Carton [18 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NBWSystem, Test, Blood Glucose, Over The Counter

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-09-05
Device Publish Date2023-08-28

On-Brand Devices [Tempo Refill Kit]

30300020947554Tempo Refill Kit - Convenience Kit for patients with diabetes, which contains lancets, testing s
50300021151558Tempo Refill Kit - This is a convenience kit which contains multiple devices with different coun

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