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510(k) Data Aggregation
K Number
K160668Device Name
HumaPen Savvio
Manufacturer
Eli Lilly and Company, Inc.
Date Cleared
2016-06-03
(86 days)
Product Code
FMF
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
Eli Lilly and Company, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
HumaPen Savvio is a reusable insulin pen intended for the self-injection of HUMALOG® (U-100, insulin lispro for injection) available in 3 mL cartridges using disposable pen needles (sold separately).
Device Description
The HumaPen Savvio is a reusable mechanical pen-injector designed for use for the self-injection of insulin. The pen-injector is intended for use with Eli Lilly and Company 3 mL insulin cartridges and single-use, detachable, and disposable pen needles (supplied separately). The pen-injector allows the user to dial the desired dose from 1 to 60 units, one unit at a time.
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K Number
K151686Device Name
HumanPen Ergo II
Manufacturer
ELI LILLY AND COMPANY, INC.
Date Cleared
2015-12-30
(190 days)
Product Code
FMF
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
ELI LILLY AND COMPANY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
HumaPen Ergo II is a reusable insulin Pen intended for the self-injection of HUMALOG® (U-100, insulin lispro for injection) available in 3 mL Cartridges using disposable Pen Needles (sold separately).
Device Description
The HumaPen Ergo II is a reusable mechanical pen-injector designed for use for the self-injection of insulin. The pen-injector is intended for use with Eli Lilly and Company 3 mL insulin cartridges and single-use, detachable, and disposable pen needles (supplied separately). The pen-injector allows the user to dial the desired dose from 1 to 60 units, one unit at a time.
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