Curaplex

GUDID 00812574024012

FILTER ONLY,26.4ID,28.4OD

TRI-ANIM HEALTH SERVICES, INC.

Pulmonary function testing filter/mouthpiece

• Primary Device ID: 00812574024012
• NIH Device Record Key: 506e3671-eef2-43c9-802b-d8d7c72f1fc5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Curaplex
• Version Model Number: 301-PFR8W
• Company DUNS: 010712461
• Company Name: TRI-ANIM HEALTH SERVICES, INC.
• 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: true
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Outer Diameter: 28.4 Millimeter
• Outer Diameter: 28.4 Millimeter
• Outer Diameter: 28.4 Millimeter
• Outer Diameter: 28.4 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812574024012 [Package]; Contains: 00812574024708; Package: [100 Units]; In Commercial Distribution
GS1	00812574024708 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042758

FDA Product Code

• BZG: SPIROMETER, DIAGNOSTIC

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-12-14

On-Brand Devices [Curaplex]

• 00812574029987: TEE,VALVED,ADL,22MM OD/OD,DISP,30/BX 12 BX/CA
• 00812574029956: TEE,VALVED,ADL,22MM OD/ID,DISP,30/BX,12BX/ CA
• 00818834020404: INFUSER,EVALUEMED,1000ML 1EA/5EA BX/25EA CS
• 00812574029796: INFUSER,EVALUEMED,500ML 1EA/5EABX/25EACS
• 00812574029659: SUCT.CATH.KIT,14FR,CUP,GRADUTD
• 00812574029635: SUCT.CATH.KIT,12FR,CUP,GRADUAT 50/CS
• 00812574029611: SUCT CATH.KIT,10FR,CUP,GRADUAT 50/CA
• 00812574029598: SUCT.CATH.KIT,8FR,CUP,GRADUATE,50/CA
• 00812574029574: SUCT.CATH,18F,COILED,GRADUATED 50/CS
• 00812574029550: SUCT.CATH,16F,COILED,GRADUATED, 50/CS
• 00812574029536: SUCTION CATH,14FR,COILED,GRADU 1/EA/50EA/CA
• 00812574029512: SUCT.CATH,10F,COILED,GRADUATED 50/CS
• 00812574029499: SUCT.CATH,8FR,COILED,GRADUATED 50/CA
• 00812574029475: SUCT.CATH,6FR,COILED,GRADUATED
• 00812574026863: DIVIDED CANNULA,7'*,2,FLR,25/
• 00812574026856: DIVIDED CANNULA,7'*,FLUER,25/C
• 00812574026849: DIVIDED CANNULA,7'*,MLUER
• 00812574026832: HIGH FLOW CANNULA,25'*
• 00812574026825: HIGH FLOW CANNULA,14'*,25/CA
• 00812574026818: HIGH FLOW CANNULA,7'*,10/CA
• 00812574026801: Nebulizer, Small Volume, Handheld, with Pediatric Aerosol Mask, 7ft Kink Resistant Tubing
• 00812574026795: Nebulizer, Small Volume, Handheld, with Adult Aerosol Mask, 7ft Kink Resistant Tubing
• 00812574026788: Nebulizer, Small Volume, Handheld, Mouthpiece, Flextube, 7 ft Tubing, Universal Connector
• 00812574026771: FILTER,C/B M/P,N/C,27.0ID,30.1OD
• 00812574026764: FILTER,N/C,27.0 ID,30.1OD
• 00812574026757: FILTER,ELLIPTICAL,27.0ID,30.1OD
• 00812574026740: FILTER,C/B M/P,27.0ID,30.1OD
• 00812574026733: FILTER ONLY,27.0 ID,30.1OD
• 00812574026726: FILTER,PFT,CURAPLEX,MOUTH PIECE,RUBBER,NOSE CLIP,26.4MM ID,28.4MM OD,FITS OLDER JAGER MODELS
• 00812574026719: FILTER,ELLIPTICAL,26.4ID,28.4OD
• 00812574026702: FILTER ONLY,26.4ID,28.4OD
• 00812574026696: FILTER,N/C,30.5ID,34OD 100/BX
• 00812574026689: FILTER,RUB M/P,N/C,30.5ID,34OD 100/BX
• 00812574026672: FILTER,ELLIPTICAL,30.5ID,34OD 100/BX
• 00812574026665: FILTER,C/B M/P,30.5ID,34OD 100/BX
• 00812574026658: FILTER,PFT,CURAPLEX,30.1MM ID,34.3MM OD,NOSECLIP,FITS OLDER JAEGER MODELS 100/BX
• 00812574026641: FILTER,PFT,CURAPLEX,30.1MM ID,34.3MM OD,FITS OLDER JAEGER MODELS 100/BX
• 00812574026634: FILTER,RUB M/P,N/C,45.5ID,48.6OD 100/BX
• 00812574026627: FILTER,ELLIPTICAL,45.5ID,48.6OD 100/BX
• 00812574026610: FILTER,RUB M/P,34.5ID,38.8OD 100/BX
• 00812574026603: FILTER,PFT,34.5ID,38.8OD,W/BITE LIP 100BX
• 00812574026597: FILTER,ELLIPTICAL,34.5ID,38.8OD 100/BX
• 00812574026580: MOUTHPIECE,RUBBER,ADLT,DISP 50/BG
• 00812574026573: HANDLE,SUCTION,YANKAUER,STRAIGHT TIP,W/O CONTROL VENT,STERILE 50/CA
• 00812574026566: PEAK FLOW METER
• 00812574026559: RESUS,SM ADL,HANDLE,MASK,OXY TUBE,RESV 10/CA
• 00812574026542: RESUS,SM ADL,MASK,OXY TUBE,RESV 10/CA
• 00812574026108: Curaplex Penlite LED Handle
• 00812574026085: Curaplex Standard LED Handle
• 00812574025958: Curaplex ClearPath HME