EXPLORAMED NC7, INC.

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Pump, Breast, Powered (HGX) (7) Shield, Nipple (HFS) (3)

Premarket Exempt

No Yes

Clear

Gen 3 Pump Kit Retail Package, White – 21mm - 00858298006552 Catalog Number : PDW53

Device Description : Gen 3 Pump Kit Retail Package, White – 21mm

Device Class : 2

Duns Number: 050917861

Premarket Exempt : No

Product Code : HGX

Prescription Use : No

Device Count : 1

Replacement Gen 3 21mm Flange - 00858298006569 Catalog Number :

Device Description : Replacement Gen 3 21mm Flange

Device Class : 2

Duns Number: 050917861

Premarket Exempt : No

Product Code : HGX

Prescription Use : No

Device Count : 1

384 ct Milk Bags (8 Softpacks) - 00858298006576 Catalog Number : B38459

Device Description : 384 ct Milk Bags (8 Softpacks)

Device Class : 2

Duns Number: 050917861

Premarket Exempt : No

Product Code : HGX

Prescription Use : No

Device Count : 1

Double Pump Kit, Willow Go - 00858298006583 Catalog Number :

Device Description : Double Pump Kit, Willow Go (Lucy)

Device Class : 2

Duns Number: 050917861

Premarket Exempt : No

Product Code : HGX

Prescription Use : No

Device Count : 1

15mm Sizing Inserts - 00858298006590 Catalog Number : SZ1562

Device Description : 15mm Sizing Inserts, Qty 2

Device Class : 1

Duns Number: 050917861

Premarket Exempt : Yes

Product Code : HFS

Prescription Use : No

Device Count : 1

17mm Sizing Inserts - 00858298006606 Catalog Number : SZ1763

Device Description : 17mm Sizing Inserts, Qty 2

Device Class : 1

Duns Number: 050917861

Premarket Exempt : Yes

Product Code : HFS

Prescription Use : No

Device Count : 1

19mm Sizing Inserts - 00858298006613 Catalog Number : SZ1763

Device Description : 19mm Sizing Inserts, Qty 2

Device Class : 1

Duns Number: 050917861

Premarket Exempt : Yes

Product Code : HFS

Prescription Use : No

Device Count : 1

Willow Go Replacement Pump - 00858298006620 Catalog Number :

Device Description : Willow Go Replacement Pump

Device Class : 2

Duns Number: 050917861

Premarket Exempt : No

Product Code : HGX

Prescription Use : No

Device Count : 1

Willow Go Flange Accessory Kit, 21 mm - 00858298006637 Catalog Number :

Device Description : Willow Go Flange Accessory Kit, 21 mm

Device Class : 2

Duns Number: 050917861

Premarket Exempt : No

Product Code : HGX

Prescription Use : No

Device Count : 1

Willow Go Flange Accessory Kit, 27 mm - 00858298006644 Catalog Number :

Device Description : Willow Go Flange Accessory Kit, 27 mm

Device Class : 2

Duns Number: 050917861

Premarket Exempt : No

Product Code : HGX

Prescription Use : No

Device Count : 1

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