FDA.reportPublic FDA data

bblüv

Primary DI
00842084000343
Brand
bblüv
Company
bbluv Group Inc
Model
B0175
Catalog number
B0175
Device description
Flöw - Portable Double Electric Breast Pump
Published
2022-03-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HGXPump, Breast, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HGXPump, Breast, PoweredObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K151284000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151284000Electric Double Breast PumpsWuxi Xinzhongrui Baby Supplies Co., Ltd.2015-12-21HGX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842084000343PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842084000343008420840003438420840003430842084000343

GMDN Terms#

Term, Definition table
TermDefinition
Breast pump, electricA mains electricity (AC-powered) device used to extract milk from the breast, typically for collecting and feeding to an infant. The device produces a continuous low-grade suction through a funnel-like component that is applied to the breast; the milk collects in an attached vessel (e.g., a sterilized bottle). The device may have a safety mechanism to prevent a potentially harmful increase in negative pressure.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-855-808-2636info@bbluvgroup.com

Regulatory Flags#

DUNS number
203630769
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06975740363477MomcozyShenzhen Root Innovation Technology Co., Ltd.HGX2026-09-20
06975740363484MomcozyShenzhen Root Innovation Technology Co., Ltd.HGX2026-09-20
06975740363750MomcozyShenzhen Root Innovation Technology Co., Ltd.HGX2026-09-20
06975740363767MomcozyShenzhen Root Innovation Technology Co., Ltd.HGX2026-09-20
00850000125506Primo PassiPrimo Passi LLCHGX2026-09-19
09420060218022haakaaTHINK GREEN LIMITEDHGX2026-09-18
09420060218053haakaaTHINK GREEN LIMITEDHGX2026-09-18
04897152760014eufy Wearable Breast PumpAnker Innovations LimitedHGX2026-08-21
07640108055903Breast shell sterile DeTach 12 mm (2 pcs)Ardo medical AGHGX2026-07-31
07640108055927Breast shell sterile DeTach 13 mm (2 pcs)Ardo medical AGHGX2026-07-31
07640108055941Breast shell sterile DeTach 14 mm (2 pcs)Ardo medical AGHGX2026-07-31
07640108055965Breast shell sterile DeTach 15 mm (2 pcs)Ardo medical AGHGX2026-07-31
07640108055989Breast shell sterile DeTach 16 mm (2 pcs)Ardo medical AGHGX2026-07-31
07640108056009Breast shell sterile DeTach 17 mm (2 pcs)Ardo medical AGHGX2026-07-31
07640108055545Breast shell sterile DeTach 18 mm (2 pcs)Ardo medical AGHGX2026-07-30
07640108055569Breast shell sterile DeTach 21 mm (2 pcs)Ardo medical AGHGX2026-07-30
07640108055583Breast shell sterile DeTach 24 mm (2 pcs)Ardo medical AGHGX2026-07-30
06925546002285ZimeituCixi Ruihong Electric Appliance Co., Ltd.HGX2026-07-28
06925546003381ZimeituCixi Ruihong Electric Appliance Co., Ltd.HGX2026-07-28
06925546033821ZimeituCixi Ruihong Electric Appliance Co., Ltd.HGX2026-07-28
06937266900017FatonePOLYBELL (GUANGZHOU) LIMITEDHGX2026-07-23
06937266900024FatonePOLYBELL (GUANGZHOU) LIMITEDHGX2026-07-23
06937266900031FatonePOLYBELL (GUANGZHOU) LIMITEDHGX2026-07-23
06937266900048FatonePOLYBELL (GUANGZHOU) LIMITEDHGX2026-07-23
06937266900055FatonePOLYBELL (GUANGZHOU) LIMITEDHGX2026-07-23
06937266900062FatonePOLYBELL (GUANGZHOU) LIMITEDHGX2026-07-23
06937266900079FatonePOLYBELL (GUANGZHOU) LIMITEDHGX2026-07-23
06937266900086FatonePOLYBELL (GUANGZHOU) LIMITEDHGX2026-07-23
06937266900093FatonePOLYBELL (GUANGZHOU) LIMITEDHGX2026-07-23
06937266900109FatonePOLYBELL (GUANGZHOU) LIMITEDHGX2026-07-23