FDA.reportPublic FDA data

Venbaby Nasal Aspirator & Saline Bundle

Primary DI
05060461080961
Brand
Venbaby Nasal Aspirator & Saline Bundle
Company
VENTURE HEALTHCARE LTD
Model
DT50
Published
2026-10-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
BTAPump, Portable, Aspiration (Manual Or Powered)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTAPump, Portable, Aspiration (Manual Or Powered)General, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K253107000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K253107000Electric Nasal Aspirator (DT10 and DT50, DX80, DX85, DX86 and DX90)Shenzhen Dongjiang Technology Co., Ltd.2026-04-14BTA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060461080961PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060461080961050604610809615060461080961

GMDN Terms#

Term, Definition table
TermDefinition
Nasal aspirator, electricA portable, hand-held, battery-powered suction device designed to enable an adult to gently suction and clear excessive mucus from the nasal passages of an infant or child to facilitate easier breathing. It consists of a handgrip that contains the batteries, a small electric pump that creates the suction, and typically has a silicone nozzle attached to a detachable, washable, collection cup at the distal end. It is designed for domestic use and is typically applied superficially the nasal opening (i.e., not inserted into the nasal cavity). This is a reusable device.

Regulatory Flags#

DUNS number
220862355
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060461080954Venbaby Nasal Aspirator and Saline Bundle DT10DT102026-10-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05060461080954Venbaby Nasal Aspirator and Saline Bundle DT10VENTURE HEALTHCARE LTDBTA2026-10-29
06978731720013Electric nasal aspiratorShenzhen Kingboom Technology Co., Ltd.BTA2026-10-12
06978731720020Electric nasal aspiratorShenzhen Kingboom Technology Co., Ltd.BTA2026-10-12
06978731720037Electric nasal aspiratorShenzhen Kingboom Technology Co., Ltd.BTA2026-10-12
06978731720044Electric nasal aspiratorShenzhen Kingboom Technology Co., Ltd.BTA2026-10-12
06978731720051Electric nasal aspiratorShenzhen Kingboom Technology Co., Ltd.BTA2026-10-12
06978731720068Electric nasal aspiratorShenzhen Kingboom Technology Co., Ltd.BTA2026-10-12
06978731720075Electric nasal aspiratorShenzhen Kingboom Technology Co., Ltd.BTA2026-10-12
06978731720082Electric nasal aspiratorShenzhen Kingboom Technology Co., Ltd.BTA2026-10-12
06978731720099Electric nasal aspiratorShenzhen Kingboom Technology Co., Ltd.BTA2026-10-12
06978731720105Electric nasal aspiratorShenzhen Kingboom Technology Co., Ltd.BTA2026-10-12
06978731720112Electric nasal aspiratorShenzhen Kingboom Technology Co., Ltd.BTA2026-10-12
06970289030866foreverlittleHetaida Technology Co., LtdBTA2026-07-28
00842429118689MV Flow Aspiration PumpMicrovention, Inc.BTA2026-07-15
06970462546832Suction PumpShenzhen HugeMed Medical Technical Development Co., Ltd.BTA2026-06-04
00860014862731HEYVALUEOak Tech LLCBTA2026-03-27
00860014862748GROWNSYOak Tech LLCBTA2026-03-27
10845854041413APEXConmed CorporationBTA2026-03-23
10845854080153CONMEDConmed CorporationBTA2026-03-23
00810149098246R&D Batteries, Inc.R & D Batteries, Inc.BTA2026-02-12
00810149098222R&D Batteries, Inc.R & D Batteries, Inc.BTA2026-01-20
00860014862700GROWNSYOak Tech LLCBTA2026-01-10
00860014862717GROWNSYOak Tech LLCBTA2026-01-10
00860014862724GROWNSYOak Tech LLCBTA2026-01-10
06973222511606Electric Nasal AspiratorShenzhen Desida Technology Co., Ltd.BTA2025-12-31
00810149098178R&D Batteries, Inc.R & D Batteries, Inc.BTA2025-10-27
00860014577550HEYVALUEOak Tech LLCBTA2025-10-13
00860014577567HEYVALUEOak Tech LLCBTA2025-10-13
00860014577574HEYVALUEOak Tech LLCBTA2025-10-13
00860014577581HEYVALUEOak Tech LLCBTA2025-10-13