FDA.reportPublic FDA data

Onset

Primary DI
00860001977318
Brand
Onset
Company
Onpharma Company
Model
540-01
Device description
Mixing Pen
Published
2020-11-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe

Contact Domains#

Product Codes#

Code, Name table
CodeName
KYWContainer, Liquid Medication, Graduated

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KYWContainer, Liquid Medication, GraduatedGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860001977318PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860001977318008600019773188600019773180860001977318

GMDN Terms#

Term, Definition table
TermDefinition
Pharmaceutical fluid-dispensing systemA assembly of devices used in a hospital and/or other healthcare facility to dispense fluids by combining in a given ratio several liquid components from a set of source containers into a container with the final product (i.e., it compounds drugs according to a specified medical prescription). It is typically a mains electricity (AC-powered) automated or semi-automated device that includes a set of standardized source liquid containers each attached with tubes to a compounding device which output is in turn attached to the final liquid container. It may also include a control panel to facilitate the introduction of manual or bar-coded mixing and/or checking instructions.

Contacts#

Phone, Email table
PhoneEmail
877-336-6738customercare@onpharma.com

Regulatory Flags#

DUNS number
081037594
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860001977356Onset41938-032025-09-19
00860001977349Onset555-012023-06-01
00860001977301Onset400452020-11-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00827989008021Health Care Logistics, Inc®Health Care Logistics, Inc.KYW2026-03-24
00827989008038Health Care Logistics, Inc®Health Care Logistics, Inc.KYW2026-03-24
00827989008045Health Care Logistics, Inc®Health Care Logistics, Inc.KYW2026-03-24
00827989008052Health Care Logistics, Inc®Health Care Logistics, Inc.KYW2026-03-24
00827989007901Health Care Logistics, Inc®Health Care Logistics, Inc.KYW2026-02-09
00827989007918Health Care Logistics, Inc®Health Care Logistics, Inc.KYW2026-02-09
00827989007925Health Care Logistics, Inc®Health Care Logistics, Inc.KYW2026-02-09
00827989007932Health Care Logistics, Inc®Health Care Logistics, Inc.KYW2026-02-09
80827989007907Health Care Logistics, Inc®Health Care Logistics, Inc.KYW2026-02-09
80827989007914Health Care Logistics, Inc®Health Care Logistics, Inc.KYW2026-02-09
80827989007921Health Care Logistics, Inc®Health Care Logistics, Inc.KYW2026-02-09
80827989007938Health Care Logistics, Inc®Health Care Logistics, Inc.KYW2026-02-09
30815112021444Mixing ContainerBracco Diagnostics Inc.KYW2026-01-09
16931918145068AllesetGRI Medical & Electronic Technology Co., Ltd.KYW2025-06-20
00661392002180LSL HEALTHCARELSL Industries, LLCKYW2025-05-16
00661392012332LSL HEALTHCARELSL Industries, LLCKYW2025-05-16
00840306835988Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KYW2025-01-16
00840306836008Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KYW2025-01-16
10827989003467Health Care Logistics, Inc®Health Care Logistics, Inc.KYW2025-01-08
10827989003474Health Care Logistics, Inc®Health Care Logistics, Inc.KYW2025-01-08
10827989003481Health Care Logistics, Inc®Health Care Logistics, Inc.KYW2025-01-08
10827989003498Health Care Logistics, Inc®Health Care Logistics, Inc.KYW2025-01-08
00616784425238Medicine Cups 1oz Dynarex CorporationKYW2024-10-28
00810180844918Medicine Cups 1oz Dynarex CorporationKYW2024-10-28
10653160381464MEDLINEMEDLINE INDUSTRIES, INC.KYW2024-10-18
16931918172811AllesetGRI Medical & Electronic Technology Co., Ltd.KYW2024-09-05
00852359007403CrushieldMAXPERT MEDICALKYW2024-05-13
10827989002095Health Care Logistics, Inc®Health Care Logistics, Inc.KYW2024-04-16
10827989002101Health Care Logistics, Inc®Health Care Logistics, Inc.KYW2024-04-16
10827989002118Health Care Logistics, Inc®Health Care Logistics, Inc.KYW2024-04-16