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

Splint, Extremity, Noninflatable, External, Sterile (FYH) (3) Tape And Bandage, Adhesive (KGX) (3) Device, Intravascular Catheter Securement (KMK) (2) Device, Fixation, Tracheal Tube (CBH) (1) Holder, Ureteral Catheter (EYJ) (1)

Premarket Exempt

No Yes

Clear

Dale Transducer Holder, 3-Tab - 00817612020841 Catalog Number : 620

Device Description : Dale Transducer Holder, Fits most

Device Class : 1

Duns Number: 001061233

Premarket Exempt : Yes

Product Code : KGX

Prescription Use : No

Device Count : 1

Dale IV Armor - 00817612020865 Catalog Number : 675

Device Description : Dale IV Armor, Flexible protective overlay, Fits most.

Device Class : 1

Duns Number: 001061233

Premarket Exempt : Yes

Product Code : KGX

Prescription Use : No

Device Count : 1

Dale Endotracheal Tube Holder - 00817612020889 Catalog Number : 280

Device Description : Dale Endotracheal Tube Holder, Fits ET Tube sizes 7.0mm - 10.0mm

Device Class : 1

Duns Number: 001061233

Premarket Exempt : Yes

Product Code : CBH

Prescription Use : No

Device Count : 1

Dale Catheter Securement Device - 00817612020902 Catalog Number : 849

Device Description : Dale IV, Arterial and Mid-line 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 - 00817612020926 Catalog Number : 848

Device Description : Dale IV Art& M-Line Catheter Securement Device Kit

Device Class : 1

Duns Number: 001061233

Premarket Exempt : Yes

Product Code : KMK

Prescription Use : Yes

Device Count : 1

Dale Transducer Holder, 2-Tab - 00817612020957 Catalog Number : 622

Device Description : Dale Transducer Holder, fits most

Device Class :

Duns Number: 001061233

Premarket Exempt : Yes

Product Code : KGX

Prescription Use : No

Device Count : 1

Dale Strapless Bendable Armboard - 00817612020971 Catalog Number : 550

Device Description : Dale Strapless Bendable Armboard, Large, 9" x 3.5"

Device Class : 1

Duns Number: 001061233

Premarket Exempt : Yes

Product Code : FYH

Prescription Use : No

Device Count : 1

Dale Strapless Bendable Armboard - 00817612020988 Catalog Number : 551

Device Description : Dale Strapless Bendable Armboard, Medium, 5.38" x 2.5"

Device Class : 1

Duns Number: 001061233

Premarket Exempt : Yes

Product Code : FYH

Prescription Use : No

Device Count : 1

Dale Strapless Bendable Armboard - 00817612021008 Catalog Number : 552

Device Description : Dale Strapless Bendable Armboard, Small, 4.5" x 1.75"

Device Class : 1

Duns Number: 001061233

Premarket Exempt : Yes

Product Code : FYH

Prescription Use : No

Device Count : 1

Dale Foley Catheter Holder - H84101501 Catalog Number : 150

Device Description : Dale Foley Catheter Holder, adhesive patch, fits most

Device Class : 1

Duns Number: 001061233

Premarket Exempt : Yes

Product Code : EYJ

Prescription Use : No

Device Count : 1

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