FDA.reportPublic FDA data

V. Mueller

Primary DI
10885403426445
Brand
V. Mueller
Company
CAREFUSION 2200, INC
Model
S-VAT-SG4800-2
Catalog number
S-VAT-SG4800-2
Device description
V. Mueller HUMAN TRIAL INST- NOT FOR SALE VATS MICT REGIONAL SET BOSTON RGNL VATS TRAY 2 SET CONTAINS TWELVE COMPONENTS
Published
2017-12-28
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
OFACardiovascular surgical instruments tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OFACardiovascular Surgical Instruments TrayCardiovascular1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10885403426445PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088540342644510885403426445

GMDN Terms#

Term, Definition table
TermDefinition
Cardiothoracic surgical procedure kit, non-medicated, reusableA collection of various sterile cardiothoracic surgical instruments dressings, and materials intended to be used to assist a range of cardiothoracic surgical procedures; it does not contain pharmaceuticals. The kit is intended only for use during cardiothoracic surgery but is not dedicated to a specific type of cardiothoracic surgical procedure. This device is reusable after appropriate cleaning/sterilization of the instruments/reusable products, and when the consumable/pharmaceutical products have been replenished.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)323-9088Customer_Support@BD.com
+1(800)548-4873xx@xx.xx

Regulatory Flags#

DUNS number
832696038
Device count
1
DM exempt
true
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
50197106720965CARDINAL HEALTHCardinal Health 200, LLCOFA2024-11-15
50197106636433CARDINAL HEALTHCardinal Health 200, LLCOFA2024-05-16
50197106457366CARDINAL HEALTHCardinal Health 200, LLCOFA2023-12-06
20809160413613Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFA2023-12-06
50197106458493CARDINAL HEALTHCardinal Health 200, LLCOFA2023-10-13
00851788001174On-X Heart Valve InstrumentsON-X LIFE TECHNOLOGIES, INC.OFA2023-08-09
00851788001730On-X Heart Valve InstrumentsON-X LIFE TECHNOLOGIES, INC.OFA2023-08-09
00851788001747On-X Heart Valve InstrumentsON-X LIFE TECHNOLOGIES, INC.OFA2023-08-09
00851788001006On-X Heart Valve InstrumentsON-X LIFE TECHNOLOGIES, INC.OFA2023-08-08
50197106140497CARDINAL HEALTHCardinal Health 200, LLCOFA2023-02-16
50195594468826CARDINAL HEALTHCardinal Health 200, LLCOFA2022-02-15
20809160360153Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFA2021-09-27
50749756714407DeRoyalDEROYAL INDUSTRIES, INC.OFA2021-06-23
50195594135926CARDINAL HEALTHCardinal Health 200, LLCOFA2021-06-10
20809160284220Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFA2020-05-28
20811870033562CUSTOM HEALTHCARE SYSTEMS, INC.CUSTOM HEALTHCARE SYSTEMS, INC.OFA2019-07-29
20811870032268Custom Healthcare Systems, Inc.CUSTOM HEALTHCARE SYSTEMS, INC.OFA2019-06-24
20811870032671Custom Healthcare Systems, Inc.CUSTOM HEALTHCARE SYSTEMS, INC.OFA2019-06-24
20811870033371Custom Healthcare Systems, Inc.CUSTOM HEALTHCARE SYSTEMS, INC.OFA2019-06-24
20811870033401Custom Healthcare Systems, Inc.CUSTOM HEALTHCARE SYSTEMS, INC.OFA2019-06-24
20811870032091Custom Healthcare Systems Inc.CUSTOM HEALTHCARE SYSTEMS, INC.OFA2019-01-23
20811870032107Custom Healthcare Systems Inc.CUSTOM HEALTHCARE SYSTEMS, INC.OFA2019-01-23
24026704522983PILLINGTELEFLEX INCORPORATEDOFA2018-09-15
10885403206474V. MuellerCAREFUSION 2200, INCOFA2018-08-17
10885403206481V. MuellerCAREFUSION 2200, INCOFA2018-08-17
50888439071144CARDINAL HEALTHCardinal Health 200, LLCOFA2018-08-03
10885403426384V. MuellerCAREFUSION 2200, INCOFA2018-01-16
10885403426421V. MuellerCAREFUSION 2200, INCOFA2018-01-16
10885403426216V. MuellerSTERIS CORPORATIONOFA2017-12-28
10885403426322V. MuellerSTERIS CORPORATIONOFA2017-12-28