DALE MEDICAL PRODUCTS, INC.

Address:40 Kenwood Circle,Franklin,MA,02038,US

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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

Device, Intravascular Catheter Securement (KMK) (5) Tape And Bandage, Adhesive (KGX) (3) Tubes, Gastrointestinal (And Accessories) (KNT) (2)

Premarket Exempt

No Yes

Clear

Dale General Purpose Securement Device - 00817612020001 Catalog Number : 952

Device Description : Dale General Purpose Securement Device, Large

Device Class : 1

Duns Number: 001061233

Premarket Exempt : Yes

Product Code : KGX

Prescription Use : No

Device Count : 1

Dale Catheter Securement Device - 00817612020025 Catalog Number : 853

Device Description : Dale CVC, PICC and Arterial Sheath Catheter Securement Device Kit

Device Class : 1

Duns Number: 001061233

Premarket Exempt : Yes

Product Code : KMK

Prescription Use : No

Device Count : 1

Dale Catheter Securement Device - 00817612020124 Catalog Number : 850

Device Description : Dale IV, Arterial and Mid-line Catheter Securement Device

Device Class : 1

Duns Number: 001061233

Premarket Exempt : Yes

Product Code : KMK

Prescription Use : No

Device Count : 1

Dale Catheter Securement Device - 00817612020148 Catalog Number : 851

Device Description : Dale IV Start Kit

Device Class : 1

Duns Number: 001061233

Premarket Exempt : Yes

Product Code : KMK

Prescription Use : No

Device Count : 1

Dale Catheter Securement Device - 00817612020162 Catalog Number : 852

Device Description : Dale CVC, PICC and Arterial Sheath Catheter Securement Device

Device Class : 1

Duns Number: 001061233

Premarket Exempt : Yes

Product Code : KMK

Prescription Use : No

Device Count : 1

Dale Catheter Securement Device - 00817612020186 Catalog Number : 854

Device Description : Dale CVC, PICC and Arterial Sheath Catheter Securement Device Kit

Device Class : 1

Duns Number: 001061233

Premarket Exempt : Yes

Product Code : KMK

Prescription Use : No

Device Count : 1

Dale General Purpose Securement Device - 00817612020209 Catalog Number : 950

Device Description : Dale General Purpose Securement Device, Small

Device Class : 1

Duns Number: 001061233

Premarket Exempt : Yes

Product Code : KGX

Prescription Use : No

Device Count : 1

Dale General Purpose Securement Device - 00817612020223 Catalog Number : 951

Device Description : Dale General Purpose Securement Device, Medium

Device Class : 1

Duns Number: 001061233

Premarket Exempt : Yes

Product Code : KGX

Prescription Use : No

Device Count : 1

Dale ACE Connector - 00817612020247 Catalog Number : 475

Device Description : The Dale ACE Connector is a plastic universal connector that provides in-line fe

Device Class : 2

Duns Number: 001061233

Premarket Exempt : No

Product Code : KNT

Prescription Use : Yes

Device Count : 1

Dale ENFit ACE Connector - 00817612020261 Catalog Number : 485

Device Description : The Dale ENFit ACE Connector is a plastic universal connector that provides in-l

Device Class : 2

Duns Number: 001061233

Premarket Exempt : No

Product Code : KNT

Prescription Use : Yes

Device Count : 1

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