FDA.report

Medline

Primary DI
40884389747422
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
DYNDJ1055
Catalog number
DYNDJ1055
Device description
KIT,ADULT TRACH DRESSING,C.H.
Published
2021-09-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
OGVTracheostomy cleaning tray

Product Code Classifications

CodeDeviceSpecialtyClass
OGVTracheostomy Cleaning TrayAnesthesiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
40884389747422PackageGS130In Commercial Distribution
10884389747421PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
4088438974742240884389747422
1088438974742110884389747421

GMDN Terms

TermDefinition
Tracheostomy care kit, single-useA collection of sterile devices and supplies intended to be used for the maintenance of a tracheostomy (i.e., removal and cleaning of tracheostomy tube prior to reinsertion). It typically includes towels, gauze, swabs, cleaning brush, and gloves. This is a single-use device.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Avoid excessive heat. Protect from freezing.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags

DUNS number
025460908
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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