FDA.report

NA

Primary DI
20653405000461
Brand
NA
Company
Conmed Corporation
Model
0036280
Catalog number
0036280
Device description
Suction Connecting Tubing, 6 Foot (1.8m) Long 1/4 Inch (6.4mm) ID
Published
2016-09-24
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
BYYTUBE, ASPIRATING, FLEXIBLE, CONNECTING

Product Code Classifications

CodeDeviceSpecialtyClass
BYYTube, Aspirating, Flexible, ConnectingGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20653405000461PackageGS150In Commercial Distribution
10653405000464PrimaryGS10
00653405000467Unit of UseGS10

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
Device Size Text, specify0
Device Size Text, specify0
Length1.8Meter
Length6Feet

Storage And Handling

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

Sterilization Methods

Method
Ethylene Oxide

Contacts

PhoneEmail
+1(800)237-0169CUSTOMER_SERVICE@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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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