FDA.reportPublic FDA data

V. Mueller

Primary DI
10885403033797
Brand
V. Mueller
Company
CAREFUSION 2200, INC
Model
CH8000-056
Catalog number
CH8000-056
Device description
MAYO INTRACARDIAC SUCKER GUARD FOR CH8000-055
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
DTSSucker, cardiotomy return, cardiopulmonary bypass

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DTSSucker, Cardiotomy Return, Cardiopulmonary BypassCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10885403033797PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088540303379710885403033797

GMDN Terms#

Term, Definition table
TermDefinition
Surgical/emergency suction cannula, non-illuminating, reusableAn 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 reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)323-9088gmb-MedSpec-CustService@carefusion.com

Regulatory Flags#

DUNS number
832696038
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
false
Expiration date on label
false
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
50382909101206Surgiphor9101209101202026-03-05
10885403273780PleurX50-007550-00752017-06-12
10885403075964PleurX50-905050-90502017-06-12
50885403075993Denver42-200042-20002017-06-12
50885403076006Denver42-205542-20552017-06-12
50885403076082Denver42-205042-20502017-06-12
10885403051722V. MuellerHY21305HY213052017-08-11
10885403049408V. MuellerGU4050-008GU4050-0082018-08-30
10885403071263V. MuellerNL1350NL13502018-09-05
10885403105159V. MuellerOS5000-002OS5000-0022018-09-10
20885403473170N/A5513E5513E2019-03-25
50885403142176Wet Exidine448944892018-07-18
50885403142183NA442044202018-07-18
50885403142190NA4461A4461A2018-07-18
50885403142220NA4472A4472A2018-07-18
50885403175211NA443744372018-07-18
50885403184473NA446844682018-07-18
50885403184480NA4469A4469A2018-07-18
50885403192829Scrub Care ExidineCLEAN1CLEAN12018-05-02
10885403465154Snowden-PencerSI325SI3252018-01-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10841742149353HNM MedicalHNM STAINLESS, LLC.DTS2025-01-27
38033178018648Suction tipSORIN GROUP ITALIA SRLDTS2024-04-04
38033178018655Suction tipSORIN GROUP ITALIA SRLDTS2024-04-04
38033178018662Suction tipSORIN GROUP ITALIA SRLDTS2024-04-04
38033178018679Suction tipSORIN GROUP ITALIA SRLDTS2024-04-04
38033178018709Suction tipSORIN GROUP ITALIA SRLDTS2024-04-04
38033178018716Suction tipSORIN GROUP ITALIA SRLDTS2024-04-04
38033178018723Suction tipSORIN GROUP ITALIA SRLDTS2024-04-04
38033178018730Suction tipSORIN GROUP ITALIA SRLDTS2024-04-04
38033178018747Suction tipSORIN GROUP ITALIA SRLDTS2024-04-04
38033178018754Suction tipSORIN GROUP ITALIA SRLDTS2024-03-20
00842962106426HNM MedicalHNM STAINLESS, LLC.DTS2024-02-09
05060660971503TEMEDTemedDTS2023-06-14
05060660971749TEMEDTemedDTS2023-06-14
00818354013955ClearView MV Atrial DepressorATRICURE, INC.DTS2016-10-24
00818354013962ClearView MV Atrial DepressorATRICURE, INC.DTS2016-10-24
B0662010350006Adult Grooved Tip SuckerNOVOSCI CORP.DTS2016-09-26
B0662010360006Pediatric Grooved Tip SuckerNOVOSCI CORP.DTS2016-09-26
B0662010370006Infant Grooved Tip SuckerNOVOSCI CORP.DTS2016-09-26
B0662010900006Adult Sump SuckerNOVOSCI CORP.DTS2016-09-26
B0662011350006Hex Handle Grooved Tip SuckerNOVOSCI CORP.DTS2016-09-26
B0662011640006Hex Handle Debridement SuckerNOVOSCI CORP.DTS2016-09-26
B0662011800006Hex Handle Tip SuckerNOVOSCI CORP.DTS2016-09-26
B0662011900006Hex Handle Adult Sump SUckerNOVOSCI CORP.DTS2016-09-26
B0662012800006Hex Handle Tip Sucker W/VentNOVOSCI CORP.DTS2016-09-26
B0662013010006Tonsil Tip SuckerNOVOSCI CORP.DTS2016-09-26
10885403033780V. MuellerCAREFUSION 2200, INCDTS2016-09-23
10885403033810V. MuellerCAREFUSION 2200, INCDTS2016-09-23
10885403033827V. MuellerCAREFUSION 2200, INCDTS2016-09-23
B15214500PEMCO INCPEMCO INCDTS2016-09-19