FDA.report

Medical Equipment Affiliates

Primary DI
40884389536620
Brand
Medical Equipment Affiliates
Company
MEDLINE INDUSTRIES, INC.
Model
DYK1101835T
Catalog number
DYK1101835T
Device description
TRAY,TRACH,BASIC,PIPE CLEANERS
Published
2021-04-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
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
40884389536620PackageGS120In Commercial Distribution
10884389536629PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
4088438953662040884389536620
1088438953662910884389536629

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.

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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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