Getinge 800 Series 8SFVUTCPAAAA

GUDID 05902533511709

STEAM STERILIZER - 833HC-E,L1,DD(LHRH),EJ,DU,HCF,RLR,REC

GETINGE IC PRODUCTION POLAND SP Z O O

Steam sterilizer

• Primary Device ID: 05902533511709
• NIH Device Record Key: 1a4d5489-db9a-42a2-aaac-e66950eae2ea
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Getinge 800 Series
• Version Model Number: 833HC
• Catalog Number: 8SFVUTCPAAAA
• 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	05902533511709 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122625

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: 1
• Public Version Date: 2021-02-19
• Device Publish Date: 2021-02-11

On-Brand Devices [Getinge 800 Series]

• 05902533510863: STEAM STERILIZER HC, 833,42-2D-RH/LH, OP30
• 05902533510856: STEAM STERILIZER HC, 833HC-E,L2,DDRH/LH,DU,PFM,RLR
• 05902533510764: STEAM STERILIZER HC, 833HC-E,L2,DD, RHLH, EJ, DU, PPM, RLR, REC/TF
• 05902533510757: Steam Sterilizer - HC, 833HC-E,L1,DDRHLH,DU/PR,PPM,RLR
• 05902533510740: Steam Sterilizer - HC, 833HC-E,L1,DDLHRH,DU/PR,PPM,RLR
• 05902533510665: STEAM STERILIZER HC, 833HC-E,L1,DDRHLH,DU,PFM,RLR, REC/TF
• 05902533510658: Steam Sterilizer - 833HC-E,L2,SDRH,EJ,DU,PFM,RLR,REC
• 05902533510641: Steam Sterilizer - 833HC-E,L2,SDLH,EJ,DU,PFM,RLR,REC
• 05902533510429: Steam Sterilizer - HC,833,76-1D-RH,Eje Stm,DU-PPM,RLR/TF,120V/60Hz,US
• 05902533510344: Steam Sterilizer -833HC-E,L2,DD,EJ,DU,PFM,RLR,REC\TF
• 05902533510313: Steam Sterilizer - 833HC-E,L2,DD,EJ,DU,PFM,RLR,REC\TF
• 05902533510290: Steam Sterilizer 833HC-E,L2,SDLH,EJ,DU,PFM,RLR,REC/TF
• 05902533510269: Steam Sterilizer - 833HC-E,L2,DD,EJ-SST,DU,PPM,RLR,REC
• 05902533510252: Steam Sterilizer - 833HC-E,L2,DDLH/RH,EJ,DU/PR,PPM,RLR,REC
• 05902533510191: Steam Sterilizer - 833HC-E,76-2D-RH,HI-VAC EJE SST,DU-PPM,120V/60Hz,US
• 05902533510160: Steam Sterilizer - HC,833,42-2D-RH/LH,Eje Stm,DU-PFM,CL,RLR,TF,120V/60Hz,US
• 05902533510092: Steam Sterilizer - 833HC-E,42-1D-RH,Eje Stm,DU-PFM,120V/60Hz,US
• 05902533505739: Steam Sterilizer - 833HC-E,42-1D-RH,Eje Stm,DU-PPM,120V/60Hz,US
• 05902533505715: Steam Sterilizer - 833HC-E,42-1D-LH,Eje Stm,DU-PPM,120V/60Hz,US
• 05902533505692: Steam Sterilizer - 833HC-E,L1,SD,LH,DU,PFM,RLR
• 05902533505678: Steam Sterilizer - 833HC-E,L1,DDRHLH,DU,PPM,RLR
• 05902533505661: Steam Sterilizer - 833HC-E,L1,DDLHRH,DU,PPM,RLR,TF
• 05902533505654: Steam Sterilizer - 833HC-E,L1,DDLHRH,DU,PPM,RLR
• 05902533505647: Steam Sterilizer - 833HC-E,L1,DDLHRH,DU,PFM,RLR
• 05902533505616: Steam Sterilizer - 833HC-E,76-1D-RH,Eje Stm,DU-PPM,120V/60Hz,US
• 05902533505609: Steam Sterilizer - 833HC-E,76-1D-RH,HI-VAC EJE SST,DU-PPM,120V/60Hz,US
• 05902533505593: Steam Sterilizer - 833HC-E,76-1D-LH,Eje Stm,DU-PPM,120V/60Hz,US
• 05902533505579: Steam Sterilizer - 833HC-E,76-2D-RH/LH,Eje Stm,DU-PPM,120V/60Hz,US
• 05902533505548: Steam Sterilizer - 833HC-E,76-2D-LH/RH,Eje Stm,DU-PPM,120V/60Hz,US
• 05902533505524: Steam Sterilizer - 833HC-E,76-2D-LH/RH,Eje Stm,DU-PFM,120V/60Hz,US
• 05902533511273: 833HC-E,L2,SDLH,EJ-SST,DU,PPM,HC,RLR,REC
• 05902533511198: 833HC-E,L1,DDRHLH,EJ,DU,PFM,HC,RLR,REC
• 05902533511358: Steam Sterilizer – 833HC-E,L1,SDRH,EJ,DU,PFM,RLR,REC/TF
• 05902533511532: STEAM STERILIZER - 833HC-E,L1,DDLHRH,DU,PFM,RLR,REC/TF
• 05902533511709: STEAM STERILIZER - 833HC-E,L1,DD(LHRH),EJ,DU,HCF,RLR,REC
• 05902533511693: STEAM STERILIZER - 833HC-E,L1,DD(LHRH),EJ,DU,HCF,RLR,REC
• 05902533511716: Steam Sterilizer - 833HC-E,L2,DD(LHRH),EJ-SST,DU,PFM,HC,RLR,REC,-,-,-
• 05902533511778: STEAM STERILIZER - 833HC-E,L1,SDLH,EJ-SST,DU,PPM,HC,RLR,REC,-,-,-
• 05902533511761: STEAM STERILIZER - 833HC-E,L1,SDRH,EJ-SST,DU,PPM,HC,RLR,REC,-,-,-
• 05902533511808: Steam Sterilizer - 833HC-E,L1,DD,EJ-SST,DU/PR,PPM,RLR,REC,-,-,-
• 05902533511792: Steam Sterilizer - 833HC-E,L1,DD,EJ-SST,DU/PR,PPM,RLR,REC,-,-,-