FDA.reportPublic FDA data

Perifit Pump

Primary DI
03770014642288
Brand
Perifit Pump
Company
X6 INNOVATIONS
Model
Perifit Pump 27mm
Published
2024-03-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

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
K231785000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231785000Perifit PumpX6 Innovations2024-01-26HGX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03770014642288PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03770014642288037700146422883770014642288

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

Regulatory Flags#

DUNS number
264648644
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03770014642486Hinge Health Pelvic Trainer by Perifit900-001102024-01-15
03770014642196Perifit Care+Purple Perifit Care+2024-01-04
03770014642134Perifit CarePink Perifit Care2023-05-12
03770014642165Perifit CareGreen Perifit Care2023-05-12
03770014642448PerifitPink Perifit2023-05-12
03770014642660PerifitGreen Perifit2023-05-12
03770014642004PerifitPink2021-08-03
03770014642226PerifitGreen Perifit2021-06-15
07109615470598PerifitPink Perifit2021-06-15
03770014642233Perifit PumpPerifit Pump 15mm2024-03-08
03770014642264Perifit PumpPerifit Pump 21mm2024-03-08
03770014642271Perifit PumpPerifit Pump 24mm2024-03-08
03770014642295Perifit PumpPerifit Pump 18mm2024-03-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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