FDA UDI In Commercial Distribution 🇺🇸 United States

Dale 244 Blue

DI: 00817612020780 · Model: 244 · DALE MEDICAL PRODUCTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1

Basic Information

Brand Name
Dale 244 Blue
Primary DI
00817612020780
Version / Model
244
Catalog Number
244
Company Name
DALE MEDICAL PRODUCTS, INC.
Labeler DUNS
001061233
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2019-05-14
Public Version
1
Public Version Date
2019-05-22
Public Version Status
New
Public Device Record Key
0e6354ac-a667-43ea-9a82-c6a2fed51b71

Device Description

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

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
No
Over the Counter (OTC)
Yes
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
Yes
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
Yes
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
CBH Device, Fixation, Tracheal Tube

GMDN Terms

Code Name
35752 Tracheostomy tube neck holder, reusable

Identifiers

Type ID
Package 00817612020797
Primary 00817612020780
Previous H84102441