FDA.reportPublic FDA data

Tempo Refill Kit

Primary DI
30300020947554
Brand
Tempo Refill Kit
Company
ELI LILLY AND COMPANY
Model
MS9599
Catalog number
MS9599001AM
Device description
Tempo Refill Kit - Convenience Kit for patients with diabetes, which contains lancets, testing strips, and BD needles.
Published
2022-11-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
NBWSystem, Test, Blood Glucose, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NBWSystem, Test, Blood Glucose, Over The CounterClinical Chemistry2

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
30300020947554PackageGS11In Commercial Distribution
00300020947553PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3030002094755430300020947554
00300020947553003000209475533000209475530300020947553

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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
006421325
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
true
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
00300021151553Tempo Refill KitMC0002MC0002001AM2023-08-28
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860015786869True IntegralTRUE INTEGRAL INCNBW2026-05-27
00860015786876True IntegralTRUE INTEGRAL INCNBW2026-05-27
08500835120024Diabetes Starter KitOptum Distribution Center, LLCNBW2026-04-21
30732671309403PipAMITY HOLDINGS, LLCNBW2026-04-16
00856362005159iHealthiHealth Labs Inc.NBW2025-12-19
10612479280486McKessonMCKESSON MEDICAL-SURGICAL INC.NBW2025-12-01
20612479280537McKessonMCKESSON MEDICAL-SURGICAL INC.NBW2025-12-01
30050428284392CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNBW2025-11-30
30050428284484CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNBW2025-11-30
10840330705681TRUE METRIX PROTRIVIDIA HEALTH, INC.NBW2025-10-02
10385540109749CareSens SAgaMatrix, Inc.NBW2025-08-04
00850044118236iHealthiHealth Labs Inc.NBW2024-05-28
00850044118243iHealthiHealth Labs Inc.NBW2024-05-27
00010939958617TRUE METRIX AIRTRIVIDIA HEALTH, INC.NBW2023-09-12
00010939958693TRUE METRIXTRIVIDIA HEALTH, INC.NBW2023-09-12
10612479265513McKessonMCKESSON MEDICAL-SURGICAL INC.NBW2023-05-17
08806128351534metene Blood Glucose Test StripAll Medicus Co.,Ltd.NBW2021-12-24
10760236150357Meijer Essential Blood Glucose MeterMEIJER, INC.NBW2021-11-05
10760236150364Meijer Essential Wireless Blood Glucose MeterMEIJER, INC.NBW2021-11-05
10760236150371Meijer Essential Blood Glucose Test StripsMEIJER, INC.NBW2021-11-05
10888277365940MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.NBW2021-10-01
00011822002783TRUE METRIX GOTRIVIDIA HEALTH, INC.NBW2021-08-31
10050428265106CVS Glucose MeterWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNBW2021-03-22
10050428293307CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNBW2021-03-22
10050428299118CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNBW2021-03-22
10888277675681MedlineMEDLINE INDUSTRIES, INC.NBW2020-12-11
10884389831205MedlineMEDLINE INDUSTRIES, INC.NBW2020-11-24
08809115905796Oh'care Lite Smart Glucose Test StripOSANG HEALTHCARE Co., Ltd.NBW2020-11-05
08809115905802Oh'care Lite Smart Glucose MeterOSANG HEALTHCARE Co., Ltd.NBW2020-11-05
08809301161760Pip Blood Glucose Test StripsPHILOSYS Co., LtdNBW2020-09-11