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, Fixation, Tracheal Tube (CBH) (4) Holder, Ureteral Catheter (EYJ) (3) Tape And Bandage, Adhesive (KGX) (3)

Premarket Exempt

No Yes

Clear

Dale Foley Catheter Holder - 00817612020544 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

Dale Foley Catheter Holder - 00817612020568 Catalog Number : 316

Device Description : Dale Foley Catheter Holder, Legband, fits up to 30"

Device Class :

Duns Number: 001061233

Premarket Exempt : Yes

Product Code : EYJ

Prescription Use : No

Device Count : 1

Dale Foley Catheter Holder - 00817612020582 Catalog Number : 330

Device Description : Dale Foley Catheter Holder, Leg band / Waist band, fits up to 56"

Device Class :

Duns Number: 001061233

Premarket Exempt : Yes

Product Code : EYJ

Prescription Use : No

Device Count : 1

Dale Nasogastric Tube Holder - 00817612020605 Catalog Number : 160

Device Description : Dale Nasogastric Tube Holder, Large/Adult

Device Class : 1

Duns Number: 001061233

Premarket Exempt : Yes

Product Code : KGX

Prescription Use : No

Device Count : 1

Dale Nasogastric Tube Holder - 00817612020629 Catalog Number : 161

Device Description : Dale Nasogastric Tube Holder, Small / Young Adult / Pediatric / Geriatric

Device Class :

Duns Number: 001061233

Premarket Exempt : Yes

Product Code : KGX

Prescription Use : No

Device Count : 1

Dale 240 Blue - 00817612020667 Catalog Number : 240

Device Description : Dale Tracheostomy Tube Holder, 1" wide, fits up to 19.5" neck.

Device Class :

Duns Number: 001061233

Premarket Exempt : Yes

Product Code : CBH

Prescription Use : No

Device Count : 1

Dale PediPrints - 00817612020704 Catalog Number : 241

Device Description : Dale PediPrints Tracheostomy Tube Holder, 1" wide, fits up to 18" neck

Device Class : 1

Duns Number: 001061233

Premarket Exempt : Yes

Product Code : CBH

Prescription Use : No

Device Count : 1

Dale PediPrints - 00817612020742 Catalog Number : 242

Device Description : Dale PediPrints Tracheostomy Tube Holder, .75" wide, fits up to 9" neck.

Device Class :

Duns Number: 001061233

Premarket Exempt : Yes

Product Code : CBH

Prescription Use : No

Device Count : 1

Dale 244 Blue - 00817612020780 Catalog Number : 244

Device Description : Dale Bariatric Tracheostomy Tube Holder, 1.5" wide, fits up to 28" neck.

Device Class : 1

Duns Number: 001061233

Premarket Exempt : Yes

Product Code : CBH

Prescription Use : No

Device Count : 1

Dale Nasal Dressing Holder - 00817612020827 Catalog Number : 600

Device Description : Dale Nasal Dressing Holder, Fits most

Device Class : 1

Duns Number: 001061233

Premarket Exempt : Yes

Product Code : KGX

Prescription Use : No

Device Count : 1

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