FDA.reportPublic FDA data

ZYPREXA® Relprevv™ 210 mg Convenience Kit

Primary DI
00300027635118
Brand
ZYPREXA® Relprevv™ 210 mg Convenience Kit
Company
ELI LILLY AND COMPANY
Model
VL7635
Catalog number
VL7635
Device description
Combination Drug/Device Convenience Kit: 1 - vial of Zyprexa Relprevv 210mg/vial (VL7635)1 - 3 mL vial of Diluent1 - 3 mL syringe w pre-attached Jelco 19-gauge 1.5 inch Hypodermic Needle-Pro need with needle protection device (EL31915 - GTIN 00351688072545) 2 - Jelco 19 gauge 1.5 inch Hypodermic Needle-Pro needles with needle protection device (EL1915 - GTIN 20351688075670)
Published
2020-06-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMINeedle, Hypodermic, Single Lumen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMINeedle, Hypodermic, Single LumenGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30300027635119PackageGS120In Commercial Distribution
00300027635118PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3030002763511930300027635119
00300027635118003000276351183000276351180300027635118

GMDN Terms#

Term, Definition table
TermDefinition
Hypodermic needle, single-useA non-dedicated, sharp bevel-edged, hollow tubular device intended to be inserted beneath the skin of a patient while connected to a noninvasive device (e.g., syringe, secondary medication set) to administer and/or withdraw (aspirate) fluids/drugs; it may also be used for fluid/drug preparation. Some types are designed with a shielding mechanism (e.g., safety cap) for protection from sharp injuries. It is not specifically designed for blood collection or artery puncture, and does not have wings for fixation/placement (i.e., not a blood collection, intra-arterial, or venous butterfly needle). This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
1-800-545-5979xxx@xxx.xxx

Regulatory Flags#

DUNS number
006421325
Device count
1
Kit
true
Combination product
true
Lot or batch
true
Serial number
true
Expiration date on label
true
No natural rubber latex
true

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

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Primary DI, Brand, Company table
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08056999020361SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
08056999020385SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
08056999020408SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
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