FDA.report

CARDINAL HEALTH

Primary DI
50195594415332
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
BN11-0007A
Catalog number
BN11-0007A
Device description
BJC TRACH CARE TRAY
Published
2021-10-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
NXATracheotomy care kit

Product Code Classifications

CodeDeviceSpecialtyClass
NXATracheotomy Care KitAnesthesiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50195594415332PackageGS120In Commercial Distribution
10195594415334PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
5019559441533250195594415332
1019559441533410195594415334

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

Regulatory Flags

DUNS number
961027315
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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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