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 The Dale ACE Connector is a plastic universal connector that provides in-line feeding, suctioning, irrigation and medication delivery while reducing the risk of potentially infectious splash back. The connector controls fluid flow into and out of most NG feeding tubes and other enteral tubes. The connector remains closed to the atmosphere, reducing the risk of cross contamination and eliminates mess and formula loss by maintaining a closed system (no disconnect). It has a simple ON/OFF handle and built in Needleless Syringe Port Seal which accepts most catheter tip 60 ml syringes. It is designed to physically prevent the administration of enteral formula into an I.V. line and is incompatible with luer connectors. The ACE Connector is DEHP free and not made with natural rubber latex.

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 The Dale ENFit ACE Connector is a plastic universal connector that provides in-line feeding, suctioning, irrigation and medication while reducing the risk of potentially infectious splash back. The connector controls fluid flow into and out of most NG feeding tubes and other enteral tubes that use the ENFit connection system. The connector remains closed to the atmosphere, reducing the risk of cross contamination and eliminates mess and formula loss by maintaining a closed system (no disconnect). It has a simple ON/OFF handle and built in Needleless Syringe Port Seal which accepts most ENFit tip syringes. It is designed to physically prevent the administration of enteral formula into an I.V. line and is incompatible with luer connectors. The ENFit ACE Connector is DEHP free and not made with natural latex rubber.

Device Class : 2

Duns Number: 001061233

Premarket Exempt : No

Product Code : KNT

Prescription Use : Yes

Device Count : 1

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