EMPAVELI® Injector

Primary DI
10851869007016
Brand
EMPAVELI® Injector
Company
Enable Injections, Inc.
Model
30129903
Catalog number
30129903
Device description
Single-use, disposable on body injector
Published
2023-10-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QLFOn-Body Injector

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QLFOn-Body InjectorGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10851869007016PackageGS18In Commercial Distribution
00851869007019PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085186900701610851869007016
00851869007019008518690070198518690070190851869007019

GMDN Terms#

Term, Definition table
TermDefinition
Elastomeric infusion pump systemAn assembly of devices that provides continuous and/or intermittent percutaneous infusion of a prescribed medicated solution to a patient through forces from elastic material. It typically consists of an elastomeric chamber (various sizes predetermine the flow and volume) that is filled with the solution using a dedicated filling device and/or syringe to create a pressure, tubing, particulate/air-eliminating filter, a flow restrictor, and a connector at the distal end for connection to the patient's access device. It may be used for general infusion, antibiotic delivery, chemotherapy, or pain management in either a healthcare facility or in the home. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature5 Degrees Celsius40 Degrees Celsius
Handling Environment Temperature41 Degrees Fahrenheit104 Degrees Fahrenheit
Storage Environment Temperature2 Degrees Celsius30 Degrees Celsius
Storage Environment Temperature36 Degrees Fahrenheit86 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-866-692-7527xx@xx.xx

Regulatory Flags#

DUNS number
961665911
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851869007019EMPAVELI® Injector30129903301299032023-10-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00851869007019EMPAVELI® InjectorEnable Injections, Inc.QLF2023-10-30
48054083023968SkyriziABBVIE INC.QLF2022-12-07
48054083023234SkyriziABBVIE INC.QLF2022-07-07