2 2 ISSN Nº 31, quarta-feira, 17 de fevereiro de 2010 E245020,E230030,E235030, E240030, E245030,) Neuroform 3 (E325010, E330010, E335010,E340010, E345010, E325015, E330015, E335015, E340015, E345015, E325020, E330020, E335020, E340020,E345020, E330030, E335030, E340030, E345030) CLASSE : IV Alteração das Instruções de Uso / Manual do Usuário/RELATÓRIO TÉCNICO e/ou Rotulagem de MATEL DE

ZPN-BS-46: Manufacturer of the medical device: SANDHILL SCIENTIFIC INC: Category Name: OESOPHAGEAL PH-METRY, PROBES: Category Code: G010301: Sign repertoire: Registered: Group of similar Medical devices: 0: Medical device reference: 0: Type: Medical Device Class: Progressive number assigned to the medical device: 139980: Effective Date ZPN-BS-46 15-18 cm esophageal length, 6 impedance (spaced 2 cm), 1 pH channel (esophageal), diameter 6.4 FR / 2.13 mm. Drawings are not to scale Catalog Number ZPN-BS-46: Event Date 12/21/2012: Event Type Malfunction Event Description Ph probe was placed while patient was in surgery. X-ray was done and showed probe was curled. Probe was pulled out some and replaced, per the physician's recommendation. Catalog Number: ZPN-BS-46 Company Name: DIVERSATEK HEALTHCARE, INC. Primary DI Number: B019ZPNBS460 Issuing Agency: HIBCC Commercial Distribution End Date:

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ZPN-BS-46 15-18 cm esophageal length, 6 impedance (spaced 2 cm), 1 pH channel (esophageal), diameter 6.4 FR / 2.13 mm. Drawings are not to scale Catalog Number ZPN-BS-46: Event Date 12/21/2012: Event Type Malfunction Event Description Ph probe was placed while patient was in surgery. X-ray was done and showed probe was curled. Probe was pulled out some and replaced, per the physician's recommendation. Catalog Number: ZPN-BS-46 Company Name: DIVERSATEK HEALTHCARE, INC. Primary DI Number: B019ZPNBS460 Issuing Agency: HIBCC Commercial Distribution End Date: ZPN-BS-46 15-18 cm esophageal length, 6 impedance (spaced 2 cm), 1 pH channel (esophageal), diameter 6.4 FR / 2.13 mm. ZPN-BS-50 15-18 cm esophageal length, 6 impedance (spaced 1.5 cm), 1 pH channel (esophageal), diameter 6.4 FR / 2.13 mm. ZPN-BG-07 15-18 cm esophageal length, 6 impedance (spaced 2 cm), 2 pH

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ZPN-BS-46 15-18 cm esophageal length, 6 impedance, 1 pH channel, diameter 6.4 FR / 2.13 mm. Acid LPR ZPI-BL-23 Esophageal reflux + acid LPR detection, 17-19 cm esophageal length, 6 impedance, 2 pH channels, -16 & 0 cm, diameter 6.9 FR / 2.3 mm. ZPI-BL-24 Esophageal reflux + acid LPR detection, 14-16 cm esophageal length, 6 impedance, medical device disposable catheter ph - vnis, vnid05, vnid10, vnid15, vnid18, vnid21, vnid7,5 New SANDHILL SCIENTIFIC ComforTec Esoppageal Impedance/pH Probe 15-18cm ZPN-BS-46E Disposables - General For Sale - DOTmed Listing #2809747: Sandhill Scientific ZPN-BS-46E ComforTec Esoppageal