RH-Pro9-230V

GUDID B234KMHRHPRO9115V4

High Velocity Hot Air Sterilizer - 230V

CPAC EQUIPMENT, INC.

Dry-heat sterilizer
Primary Device IDB234KMHRHPRO9115V4
NIH Device Record Key7eb78df4-9f8d-4d17-abb5-a5e8cf768d3d
Commercial Distribution StatusIn Commercial Distribution
Brand NameRH-Pro9-230V
Version Model NumberRH-Pro9-230V
Company DUNS601985976
Company NameCPAC EQUIPMENT, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB234KMHRHPRO9115V4 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KMHSterilizer, Dry Heat

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-10-09
Device Publish Date2020-10-01

Devices Manufactured by CPAC EQUIPMENT, INC.

B234KMHRHPRO111230V1 - RH-Pro11-230V2020-10-09 High Velocity Hot Air Sterilizer - 230V
B234KMHRHPRO9115V3 - RH-Pro92020-10-09 High Velocity Hot Air Sterilizer - 115V
B234KMHRHPRO9115V4 - RH-Pro9-230V2020-10-09High Velocity Hot Air Sterilizer - 230V
B234KMHRHPRO9115V4 - RH-Pro9-230V2020-10-09 High Velocity Hot Air Sterilizer - 230V
B234FRGSTMS400633 - STERIDENT2020-04-13 Spore Test Monitoring Service Dry Heat or Steam, Mail-in 12/box
B234FRGSTMS400634 - STERIDENT2020-04-13 SPORE TEST KIT MONITORING SERVICE DRY HEAT OR STEAM, MAIL IN 52/BOX
B234FRGDHSB400597 - STERISURE2019-11-08 STERISURE DRY HEAT STERILIZER BAGS, PAPER 2.5" X 1.5" X 10.5", 250/BOX
B234FRGSSNP400636 - STERIDENT2019-11-08 Self-Seal Nylon Pouches 2" x 10" 100/Box
B234FRGSSNP400637 - STERIDENT2019-11-08 Self-Seal Nylon Pouches 4" x 10" 100/Box

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