FDA.reportPublic FDA data

NA

Primary DI
20653405054099
Brand
NA
Company
Conmed Corporation
Model
8888
Catalog number
8888
Device description
COLON CLEANSING NOZZLE WITH BULB TIP FOR COLONIC IRRIGATION DEVICES
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
GCXAPPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCXApparatus, Suction, Operating-Room, Wall Vacuum PoweredGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20653405054099PackageGS150In Commercial Distribution
10653405054092PrimaryGS10
00653405054095Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2065340505409920653405054099
1065340505409210653405054092
00653405054095006534050540956534050540950653405054095

GMDN Terms#

Term, Definition table
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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature10 Degrees Celsius32 Degrees Celsius
Storage Environment Temperature50 Degrees Fahrenheit90 Degrees Fahrenheit

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10845854051399AirSealiAS8-dViAS8-dV2021-08-22
10845854084137AirSeal®iAS8-dVLiAS8-dVL2023-01-06
20653405037573CONMEDPCD10PCD102016-09-24
10653405063797CONMED75200752002026-03-24
00845854035590CONCEPTESA-5190ESA-51902026-03-24
10845854041116POWERPROPRO2000PRO20002026-03-24
10845854041291CONMEDLS7501LS75012026-03-24
00653405014952POOLE903507090350702026-03-24
20653405017759CONMEDD8324D83242026-03-24
20653405017766CONMEDD8324IID8324II2026-03-24
20653405019777CONMEDDA36-03DA36-032026-03-24
20653405022821CONMEDFSR1303FSR13032026-03-24
20653405022838CONMEDFSR1311FSR13112026-03-24
20653405022951CONMEDFSR1370FSR13702026-03-24
20653405023057CONMEDFSR1534FSR15342026-03-24
20653405023071CONMEDFSR1539FSR15392026-03-24
20653405023163CONMEDFSR1590FSR15902026-03-24
20653405023170CONMEDFSR1590-20FSR1590-202026-03-24
20653405023385CONMEDFSR380FSR3802026-03-24
20653405023545CONMEDFSR565FSR5652026-03-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00653405014952POOLEConmed CorporationGCX2026-03-24
50198956355475CARDINAL HEALTHCardinal Health 200, LLCGCX2026-03-19
50198956417999CARDINAL HEALTHCardinal Health 200, LLCGCX2026-03-16
G8057116571Bleed IDAPARATA MEDICAL, LLCGCX2026-03-02
50198956375640CARDINAL HEALTHCardinal Health 200, LLCGCX2026-02-13
50198956277937CARDINAL HEALTHCardinal Health 200, LLCGCX2026-01-22
20889483228743Muc-Away™SUNMED, LLCGCX2025-12-31
20889483228750Muc-Away™SUNMED, LLCGCX2025-12-31
20889483230111Muc-Away™SUNMED, LLCGCX2025-12-31
10889483230121Muc-Away™SUNMED, LLCGCX2025-12-31
50198956261806CARDINAL HEALTHCardinal Health 200, LLCGCX2025-12-17
50192253043363CARDINAL HEALTHCardinal Health 200, LLCGCX2025-12-16
50192253043370CARDINAL HEALTHCardinal Health 200, LLCGCX2025-12-16
50192253043387CARDINAL HEALTHCardinal Health 200, LLCGCX2025-12-16
50192253043394CARDINAL HEALTHCardinal Health 200, LLCGCX2025-12-16
50192253043400CARDINAL HEALTHCardinal Health 200, LLCGCX2025-12-16
50192253043417CARDINAL HEALTHCardinal Health 200, LLCGCX2025-12-16
50198956252125CARDINAL HEALTHCardinal Health 200, LLCGCX2025-11-25
20816286021189Boehringer Surgical Suction DeviceBOEHRINGER LABORATORIES, LLCGCX2025-11-24
50198956160857CARDINAL HEALTHCardinal Health 200, LLCGCX2025-08-27
50198956180381CARDINAL HEALTHCardinal Health 200, LLCGCX2025-08-27
00194613008253MSI Precision Specialty InstrumentsMed Saver, Inc.GCX2025-08-01
00194613019945MSI Precision Specialty InstrumentsMed Saver, Inc.GCX2025-08-01
00194613019952MSI Precision Specialty InstrumentsMed Saver, Inc.GCX2025-08-01
00194613021504MSI Precision Specialty InstrumentsMed Saver, Inc.GCX2025-08-01
00194613021511MSI Precision Specialty InstrumentsMed Saver, Inc.GCX2025-08-01
00194613021627MSI Precision Specialty InstrumentsMed Saver, Inc.GCX2025-08-01
00194613021634MSI Precision Specialty InstrumentsMed Saver, Inc.GCX2025-08-01
00194613021641MSI Precision Specialty InstrumentsMed Saver, Inc.GCX2025-08-01
00194613021665MSI Precision Specialty InstrumentsMed Saver, Inc.GCX2025-08-01