Dale 200 One Piece Holder 200

GUDID H84102002

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

DALE MEDICAL PRODUCTS, INC.

Tracheostomy tube neck holder, reusable
Primary Device IDH84102002
NIH Device Record Keye9255e5b-2591-46f9-a8ab-3e5e35786ce8
Commercial Distribution StatusIn Commercial Distribution
Brand NameDale 200 One Piece Holder
Version Model Number200
Catalog Number200
Company DUNS001061233
Company NameDALE MEDICAL PRODUCTS, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCH84102001 [Primary]
HIBCCH84102002 [Package]
Contains: H84102001
Package: Box [30 Units]
In Commercial Distribution

FDA Product Code

CBHDevice, Fixation, Tracheal Tube

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-09-27
Device Publish Date2018-08-27

Devices Manufactured by DALE MEDICAL PRODUCTS, INC.

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