FDA.report

CARDINAL HEALTH

Primary DI
10885380072406
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
K85
Catalog number
K85
Device description
Medi Vac Yankauer Suction Handle with Tapered Bulbous Tip and Non-Conductive Suction Tubing 6 mm x 3.7 m (12 ft)
Published
2016-08-26
Public version status
Update
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
JOLCATHETER AND TIP, SUCTION

Product Code Classifications

CodeDeviceSpecialtyClass
JOLCatheter And Tip, SuctionGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50885380072404PackageGS125In Commercial Distribution
10885380072406PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
5088538007240450885380072404
1088538007240610885380072406

GMDN Terms

TermDefinition
Surgical/emergency suction cannula, non-illuminating, single-useAn atraumatic, invasive, hand-operated, single-lumen, rigid/semi-rigid tube designed as a conduit for aspiration of body cavities, wounds, or surgical sites to facilitate observation and/or to clear an airway obstruction. It is not dedicated to dental, intrauterine, or liposuction procedures, and is neither an ophthalmic nor an intravascular device; it is not designed for surgical irrigation. Sometimes referred to as a suction tube or tip, it may incorporate a handle with side valve(s)/hole(s), and may be provided with a stylet, sheath, and/or connection tubing; it does not include a light source or fibreoptic bundle. This is a single-use device.

Device Sizes

TypeValueUnit
Length12Feet
Lumen/Inner Diameter0.24Inch

Sterilization Methods

Method

Regulatory Flags

DUNS number
961027315
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
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
false
Sterilization required before use
false

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