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) (8) Tape And Bandage, Adhesive (KGX) (2)

Premarket Exempt

No Yes

Clear

Dale Nasogastric Tube Holder - H84101601 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 - H84101611 Catalog Number : 161

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

Device Class : 1

Duns Number: 001061233

Premarket Exempt : Yes

Product Code : KGX

Prescription Use : No

Device Count : 1

Dale 200 One Piece Holder - H84102001 Catalog Number : 200

Device Description : Dale One Piece tracheostomy tube holder, 1" wide neckband, fits 9.5" to 18" neck.

Device Class : 1

Duns Number: 001061233

Premarket Exempt : Yes

Product Code : CBH

Prescription Use : No

Device Count : 1

Dale 240 Blue - H84102401 Catalog Number : 240

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

Device Class : 1

Duns Number: 001061233

Premarket Exempt : Yes

Product Code : CBH

Prescription Use : No

Device Count : 1

Dale PediPrints - H84102411 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 - H84102421 Catalog Number : 242

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

Device Class : 1

Duns Number: 001061233

Premarket Exempt : Yes

Product Code : CBH

Prescription Use : No

Device Count : 1

Dale 244 Blue - H84102441 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 Endotracheal Tube Holder - H84102701 Catalog Number : 270

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 Adhesive Base - H84102731 Catalog Number : 273

Device Description : Dale Adhesive Base for Dale 270 and 280

Device Class : 1

Duns Number: 001061233

Premarket Exempt : Yes

Product Code : CBH

Prescription Use : No

Device Count : 1

Dale Endotracheal Tube Holder - H84102801 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

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