Getinge 400 Series 4SSPUPHRTDAA

GUDID 05902533510726

Steam Sterilizer – 433HC-E,L1,SD,EJ-SST,DU,PWR,R+2,REC/TF,380/SST

GETINGE IC PRODUCTION POLAND SP Z O O

Steam sterilizer

• Primary Device ID: 05902533510726
• NIH Device Record Key: 91c47c68-3094-4280-8fe2-96e00a3a26ec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Getinge 400 Series
• Version Model Number: 433HC
• Catalog Number: 4SSPUPHRTDAA
• Company DUNS: 427370513
• Company Name: GETINGE IC PRODUCTION POLAND SP Z O O
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	05902533510726 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122071

FDA Product Code

• FLE: Sterilizer, Steam

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-05-15

On-Brand Devices [Getinge 400 Series]

• 05902533510788: Steam Sterilizer – 433HC-E,L1,SD,EJ-SST,DU,PWR,R+2,REC/TF,380/BD SST
• 05902533510771: Steam Sterilizer – 433HC-E,L1,SD,EJ-SST,DU,MAN,R+2,REC/TF,380/BD SST
• 05902533510726: Steam Sterilizer – 433HC-E,L1,SD,EJ-SST,DU,PWR,R+2,REC/TF,380/SST
• 05902533510597: Steam Sterilizer – 433HC-E,L1,SD,460 VPS SST,PWR,R+2
• 05902533510580: Steam Sterilizer – 433HC-E,L1,SD,EJ-SST,DU,PWR,R+2,208/BD SST
• 05902533510467: Steam Sterilizer – 433HC-E,L1,SD,EJ-SST,DU,PWR,R+2,REC,460/BD SST
• 05902533510337: Steam Sterilizer - 433HC-E,L1,SD,DU,MAN,R2,600BD
• 05902533500512: Steam Sterilizer - 433HC-E,L1,SD,DU,PWR,R2,380,TF
• 05902533500437: Steam Sterilizer - 433HC-E,L1,SD,DU,PWR,R2,480
• 05902533500420: Steam Sterilizer - 433HC-E,L1,SD,DU,PWR,R2,208
• 05902533500413: Steam Sterilizer - 433HC-E,L1,SD,DU,PWR,R2
• 05902533500406: Steam Sterilizer - 433HC-E,L1,SD,DU,PWR,R2,480BD
• 05902533500390: Steam Sterilizer - 433HC-E,L1,SD,DU,PWR,R2,240BD
• 05902533500383: Steam Sterilizer - 433HC-E,L1,SD,DU,PWR,R2,208BD
• 05902533500260: Steam Sterilizer - 433HC-E,L1,SD,DU,MAN,R2,460BD,TF
• 05902533500208: Steam Sterilizer - 433HC-E,L1,SD,DU,MAN,R2,460
• 05902533500192: Steam Sterilizer - 433HC-E,L1,SD,DU,MAN,R2,208
• 05902533500185: Steam Sterilizer - 433HC-E,L1,SD,DU,MAN,R2
• 05902533500178: Steam Sterilizer - 433HC-E,L1,SD,DU,MAN,R2,460BD
• 05902533500161: Steam Sterilizer - 433HC-E,L1,SD,DU,MAN,R2,208BD
• 05902533500154: Steam Sterilizer - 433HC-E,L1,SD,DU,VP,PWR,R2
• 05902533500031: Steam Sterilizer - 433HC-E,L1,DD,DU,PWR,R2
• 05902533500017: Steam Sterilizer - 433HC-E,L1,DD,DU,MAN,R2
• 05902533511006: Steam Sterilizer – 433HC-E,L1,SD,EJ,DU,MAN,R+2,REC/TF,460
• 05902533511068: Steam Sterilizer - 433HC-E,L1,SD,460 VPS SST,DU,MAN,R+2,REC
• 05902533511051: Steam Sterilizer - 433HC-E,L1,SD,208 VPS SST,DU,MAN,R+2,REC
• 05902533511341: Steam Sterilizer – 433HC-E,L1,SD,EJ,DU,MAN,R+2,REC/TF,230
• 05902533511334: Steam Sterilizer – 433HC-3,L1,SD,EJ,DU,MAN,R+2,REC,230
• 05902533511525: Steam sterilizer - 433HC-E,L1,SD,EJ,DU,PWR,R+2,REC,380/BD
• 05902533511440: Steam Sterilizer – 433HC-E,L1,SD,208 VPS BRASS,DU,PWR,R+2,REC
• 05902533511433: Steam Sterilizer – 433HC-E,L1,SD,208 VPS BRASS,DU,MAN,R+2,REC
• 05902533511419: Steam Sterilizer – 433HC-E,L1,SD,EJ,DU,PWR,R+2,REC,380
• 05902533511426: Steam Sterilizer – 433HC-E,L1,DD,208 VPS BRASS,DU,PWR,R+2,REC
• 05902533511570: STEAM STERILIZER HC - 433HC-E,L1,DD,DU,PWR,R2,208
• 05902533511594: Steam Sterilizer – 433HC-E,L1,SD,EJ,DU,MAN,R+2,REC/TF,380
• 05902533548743: Steam Sterilizer – 433HC-E, L1, SD, EJ SST, DU,PWR,R2