FDA.reportPublic FDA data

Shenzhen Bona Pharma

Primary DI
06976262370240
Brand
Shenzhen Bona Pharma
Company
Shenzhen Bona Pharma Technology Co., Ltd.
Model
SC-CRN
Published
2026-03-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
EPNPump, Nebulizer, Manual

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EPNPump, Nebulizer, ManualEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06976262370240PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06976262370240069762623702406976262370240

GMDN Terms#

Term, Definition table
TermDefinition
Medication spray nozzleA tubular device with an atomizing distal tip intended to be attached to the container (e.g., squeeze bottle, syringe) of a medication (e.g., local anaesthetic) [not included] for administration of the medication in spray (atomized) form. It may be used externally (i.e., on skin) and/or non-surgical invasively via a natural orifice (e.g., oral, laryngeal) during a clinical procedure (e.g., endotracheal intubation, prior to percutaneous injection); it is typically made of polymer materials. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
526903769
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00864915000339Tian MedicalTian Medical, LLCEPN2024-04-05
20864915000302Tian MedicalTian Medical, LLCEPN2024-04-05
00864915000308Tian MedicalTian Medical, LLCEPN2021-05-18
00817081026382Nebulizer, Hand Held, Tee AdapterA-M SYSTEMS, LLCEPN2020-04-10
00817081026405Nebulizer, Hand HeldA-M SYSTEMS, LLCEPN2020-04-10
00817081026429Nebulizer, Hand HeldA-M SYSTEMS, LLCEPN2020-04-10
00817081026399Nebulizer, Hand Held, Tee AdapterA-M SYSTEMS, LLCEPN2020-04-10
00817081026412Nebulizer, Hand HeldA-M SYSTEMS, LLCEPN2020-04-10
00817081026436Nebulizer, Hand HeldA-M SYSTEMS, LLCEPN2020-04-10
00817081026443Innospire MiniA-M SYSTEMS, LLCEPN2020-04-10
00817081026450Option Home w/ Side Stream, Disposable NebulizerA-M SYSTEMS, LLCEPN2020-04-10
00817081026320Nebulizer, Side Stream, DisposableA-M SYSTEMS, LLCEPN2020-04-09
00817081026368Nebulizer, Hand Held, Tee AdapterA-M SYSTEMS, LLCEPN2020-04-09
00817081026337Nebulizer, Side Stream, DisposableA-M SYSTEMS, LLCEPN2020-04-09
00817081026344Nebulizer, Side Stream, Re-UsableA-M SYSTEMS, LLCEPN2020-04-09
00817081026375Nebulizer, Hand Held, Tee AdapterA-M SYSTEMS, LLCEPN2020-04-09
00817081026306"Nebulizer, Hand Held, Tee Adapter, 84"" Tube"A-M SYSTEMS, LLCEPN2020-04-06
00817081026313Nebulizer, Hand Held, Tee Adapter, 84" TubeA-M SYSTEMS, LLCEPN2020-04-06