Two Piece Tracheostomy Tie Pediatric 2cm x 35.5cm (14in)

GUDID 10848530103559

Pediatric Two Piece Trach Ties, 2x35.5cm (14in) - 20/box

SUNSET HEALTHCARE SOLUTIONS, INC.

Tracheostomy tube neck holder, single-use
Primary Device ID10848530103559
NIH Device Record Key073758e7-3390-4fde-9cf4-8166a277ab25
Commercial Distribution StatusIn Commercial Distribution
Brand NameTwo Piece Tracheostomy Tie Pediatric 2cm x 35.5cm (14in)
Version Model NumberRES030P-14
Company DUNS141668116
Company NameSUNSET HEALTHCARE SOLUTIONS, 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 Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100848530103552 [Primary]
GS110848530103559 [Package]
Contains: 00848530103552
Package: [20 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 Date2024-03-28
Device Publish Date2024-03-20

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