HME Flex HME-712-Flex

GUDID 10850014574816

HME with Flex Tube

PEPPER MEDICAL INC.

Heat/moisture exchanger, single-use
Primary Device ID10850014574816
NIH Device Record Key71ea3194-4c6b-4ffc-8a35-bceb9d5968e8
Commercial Distribution StatusIn Commercial Distribution
Brand NameHME Flex
Version Model NumberHME-712-Flex
Catalog NumberHME-712-Flex
Company DUNS622637098
Company NamePEPPER MEDICAL INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)647-0172
Emailgschuster@peppermedical.com
Phone+1(800)647-0172
Emailgschuster@peppermedical.com
Phone+1(800)647-0172
Emailgschuster@peppermedical.com
Phone+1(800)647-0172
Emailgschuster@peppermedical.com
Phone+1(800)647-0172
Emailgschuster@peppermedical.com
Phone+1(800)647-0172
Emailgschuster@peppermedical.com
Phone+1(800)647-0172
Emailgschuster@peppermedical.com
Phone+1(800)647-0172
Emailgschuster@peppermedical.com
Phone+1(800)647-0172
Emailgschuster@peppermedical.com
Phone+1(800)647-0172
Emailgschuster@peppermedical.com
Phone+1(800)647-0172
Emailgschuster@peppermedical.com
Phone+1(800)647-0172
Emailgschuster@peppermedical.com
Phone+1(800)647-0172
Emailgschuster@peppermedical.com
Phone+1(800)647-0172
Emailgschuster@peppermedical.com
Phone+1(800)647-0172
Emailgschuster@peppermedical.com
Phone+1(800)647-0172
Emailgschuster@peppermedical.com
Phone+1(800)647-0172
Emailgschuster@peppermedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS110850014574793 [Primary]
GS110850014574816 [Package]
Contains: 10850014574793
Package: Box [25 Units]
In Commercial Distribution

FDA Product Code

BYDCONDENSER, HEAT AND MOISTURE (ARTIFICIAL NOSE)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-11-02
Device Publish Date2023-10-25

Devices Manufactured by PEPPER MEDICAL INC.

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10850014574885 - Pepper Medical Closed Suction2025-09-23 Closed Suction Catheter, 8 French
10850014574908 - Pepper Medical Closed Suction2025-09-23 Closed Suction Catheter, 12 French
10850014575066 - Pepper Medical Closed Suction2025-09-23 Closed Suction Catheter, 16 French
10850014574823 - Pepper Medical Closed Suction2025-09-19 Closed Suction Catheter, 14 French
10850014574946 - Pepper Medical Closed Suction2025-09-19 Closed Suction Catheter, 8 French
10850014574960 - Pepper Medical Closed Suction2025-09-19 Closed Suction Catheter, 10 French

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