FDA.reportPublic FDA data

Tempo Refill Kit

Primary DI
00300021151553
Brand
Tempo Refill Kit
Company
ELI LILLY AND COMPANY
Model
MC0002
Catalog number
MC0002001AM
Device description
Tempo Refill Kit - This is a convenience kit which contains multiple devices with different counts: Lancets/Strips/BD needles and gauze pads.
Published
2023-08-28
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMINeedle, Hypodermic, Single Lumen
FMKSingle Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
NBWSystem, Test, Blood Glucose, Over The Counter
OCNInsulin Autoantibody Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMINeedle, Hypodermic, Single LumenGeneral Hospital2
FMKSingle Use Only Blood Lancet With An Integral Sharps Injury Prevention FeatureGeneral, Plastic Surgery2
NBWSystem, Test, Blood Glucose, Over The CounterClinical Chemistry2
OCNInsulin Autoantibody KitImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K212217000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212217000Tempo Smart ButtonEli Lilly and Company2022-09-16QOG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50300021151558PackageGS118Not in Commercial Distribution
00300021151553PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5030002115155850300021151558
00300021151553003000211515533000211515530300021151553

GMDN Terms#

Term, Definition table
TermDefinition
Glucose monitoring system IVD, home-useA collection of devices including a portable, battery-powered, semi-automated or automated instrument (self-testing meter), reagents, test strips and/or other associated materials and accessories (e.g., control solutions, lancets) intended to be used for the quantitative measurement of glucose in a whole blood clinical specimen; it is designed to be used for self-testing by a layperson in the home, and some types may in addition be used at the point-of-care. Measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity20 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature34 Degrees Fahrenheit86 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
1-855-545-5983xx@xxx.xxx

Regulatory Flags#

DUNS number
006421325
Device count
1
Kit
true
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00300020948550Tempo Welcome KitMS9841MS9841001AM2022-11-01
00300020911554Tempo Smart ButtonMS6303MS63032022-11-01
30300020948551Tempo Welcome KitMS9841MS9841001AM2022-11-01
00300021451554Lilly TogetherMA9142 IOS (Version 17)MA9142001AM2025-04-17
00300021458553Lilly TogetherMA9141 Android (Version 17)MA9141001AM2025-04-17
00300021285555Lilly TogetherMA9161 Android (Version 15)MA9161001AM2024-11-26
00300021286552Lilly TogetherMA9162 IOS (Version 15)MA9162001AM2024-11-26
00300021283551Lilly TogetherMA9159 Android (Version 14)MA9159001AM2024-07-26
00300021284558Lilly TogetherMA9160 IOS (Version 14)MA9160001AM2024-07-26
00300021176556Lilly TogetherMA9152 Android (Version 13)MA9152001AM2024-03-11
00300021177553Lilly TogetherMA9158 IOS (Version 13)MA9158001AM2024-03-11
00300021174552Lilly TogetherMA9135 ANDROID (Version 12) MA9135001AM2024-02-16
00300021175559Lilly TogetherMA9140 IOS (Version 12)MA9140001AM2024-02-16
00300021107550Lilly TogetherMA7723 IOSMA7723001AM2022-10-25
00300021109554Lilly TogetherMA9131 AndroidMA9131001AM2022-10-25
00300020947553Tempo Refill KitMS9599MS9599001AM2022-11-01
00300029561019HumatroPen® 12 mg MS9561MS95612019-09-16
00300029562016HumatroPen® 24 mg MS9562MS95622019-09-16
00300029675013HumaPen® Luxura™ HD - SAMPLEMS9675MS96752017-05-25
00300029560012HumatroPen® 6 mgMS9560MS95602019-09-16

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