Search Results
Found 2 results
510(k) Data Aggregation
K Number
K063151Device Name
HUMAPEN LUXURA HD
Manufacturer
ELI LILLY AND CO.
Date Cleared
2007-01-09
(85 days)
Product Code
NSC
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
ELI LILLY AND CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The HumaPen Luxura HD is a reusable pen injector designed for use by diabetics for the self-injection of a desired dose of insulin. The pen injector uses 3.0 mL cartridges of Lilly insulin and a single use detachable and disposable pen needle (supplied separately). The pen injector allows the user to dial the desired dose from 1 to 30 units in one-half (1/2) unit increments.
Device Description
HumaPen Luxura HD is a reusable mechanical pen-injector designed for the selfinjection 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).
Ask a Question
K Number
K982842Device Name
HUMAPEN AND HUMAPEN ERGO
Manufacturer
ELI LILLY AND CO.
Date Cleared
1998-09-25
(44 days)
Product Code
FMF
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
ELI LILLY AND CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The HumaPen and the HumaPen Ergo are two versions of a reusable pen-injector designed for use by diabetics for the self-injection of a desired dose of insulin. The peninjector uses 3.0 mL cartridges of insulin (Humalog® or Humulin®) and a single use, detachable and disposable pen needle (supplied separately). The pen-injector allows the user to dial the desired dose one unit at a time up to 60 units.
Device Description
HumaPen and HumaPen Ergo are two versions of a reusable pen-injector designed for use by diabetics for the self-injection of a desired dose of insulin. The pen-injector uses 3.0 mL cartridges of insulin (Humalog® (human insulin[rDNA origin]) or Humulin® (insulin lispro injection [rDNA origin]) and a single use, detachable and disposable pen needle (supplied separately). The peninjector allows the user to dial the desired dose one unit at a time up to 60 units.
Ask a Question
Page 1 of 1