FDA.report

YANKAUER

Primary DI
00653405014907
Brand
YANKAUER
Company
Conmed Corporation
Model
9034950
Catalog number
9034950
Device description
YANKAUER SUCTION INSTRUMENT WITHOUT CONTROL VENT, STANDARD TIP WITH 10' (3.0M) CLEAR PLASTIC TUBING, PRE-ATTACHED
Published
2020-12-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
GCXAPPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED

Product Code Classifications

CodeDeviceSpecialtyClass
GCXApparatus, Suction, Operating-Room, Wall Vacuum PoweredGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
40653405014905PrimaryGS10
00653405014907Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
4065340501490540653405014905
00653405014907006534050149076534050149070653405014907

GMDN Terms

TermDefinition
Suction/irrigation tubing, single-useA length of flexible noninvasive tube, typically made of synthetic polymer material(s), intended to interface between suction and/or irrigation devices (e.g., catheters, pumps, collection bottles) during a medical/surgical procedure. The tubing may be provided in rolls from which required lengths are cut, or may be provided in predetermined lengths with connectors; it does not include additional associated items such as a clamp, spike, or bag (i.e., not a tubing set). This is a single-use device.

Device Sizes

TypeValueUnit
Length3Meter
Length10Feet

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature10 Degrees Celsius32 Degrees Celsius
Storage Environment Temperature50 Degrees Fahrenheit90 Degrees Fahrenheit

Sterilization Methods

Method

Contacts

PhoneEmail
+1(866)426-6633CustomerExperience@conmed.com

Regulatory Flags

DUNS number
071595540
Device count
50
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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