Breathing bags

GUDID 06972249260245

Shandong Jinlai Huanhai Medical Technology Co., Ltd.

Breathing circuit bag, single-use
Primary Device ID06972249260245
NIH Device Record Key4ae19917-5b6e-46b6-9b14-104bb7a813cf
Commercial Distribution StatusIn Commercial Distribution
Brand NameBreathing bags
Version Model NumberHH-HHN-ATW-0.25L
Company DUNS420187530
Company NameShandong Jinlai Huanhai Medical Technology Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106972249260245 [Primary]

FDA Product Code

BTCBag, Reservoir

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[06972249260245]

Ethylene Oxide


[06972249260245]

Ethylene Oxide


[06972249260245]

Ethylene Oxide


[06972249260245]

Ethylene Oxide


[06972249260245]

Ethylene Oxide


[06972249260245]

Ethylene Oxide


[06972249260245]

Ethylene Oxide


[06972249260245]

Ethylene Oxide


[06972249260245]

Ethylene Oxide


[06972249260245]

Ethylene Oxide


[06972249260245]

Ethylene Oxide


[06972249260245]

Ethylene Oxide


[06972249260245]

Ethylene Oxide


[06972249260245]

Ethylene Oxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-03-11
Device Publish Date2025-03-03

On-Brand Devices [Breathing bags]

06972249260078HH-HHN-B-3L
06972249260061HH-HHN-B-2L
06972249260054HH-HHN-B-1L
06972249260047HH-HHN-B-0.5L
06972249260030HH-HHN-A-3L
06972249260023HH-HHN-A-2L
06972249260016HH-HHN-A-1L
06972249260009HH-HHN-A-0.5L
06972249261198HH-HHN-DE-6L
06972249261181HH-HHN-DE-5L
06972249261174HH-HHN-DE-4L
06972249261167HH-HHN-DE-3L
06972249261150HH-HHN-DE-2L
06972249261143HH-HHN-DE-1L
06972249261136HH-HHN-DE-0.5L
06972249261129HH-HHN-DE-0.25L
06972249261112HH-HHN-DT-6L
06972249261105HH-HHN-DT-5L
06972249261099HH-HHN-DT-4L
06972249261082HH-HHN-DT-3L
06972249261075HH-HHN-DT-2L
06972249261068HH-HHN-DT-1L
06972249261051HH-HHN-DT-0.5L
06972249261044HH-HHN-DT-0.25L
06972249261037HH-HHN-D-6L
06972249261020HH-HHN-D-5L
06972249261013HH-HHN-D-4L
06972249261006HH-HHN-D-3L
06972249260993HH-HHN-D-2L
06972249260986HH-HHN-D-1L
06972249260979HH-HHN-D-0.5L
06972249260962HH-HHN-D-0.25L
06972249260955HH-HHN-AH-6L
06972249260948HH-HHN-AH-5L
06972249260931HH-HHN-AH-4L
06972249260924HH-HHN-AH-3L
06972249260917HH-HHN-AH-2L
06972249260900HH-HHN-AH-1L
06972249260894HH-HHN-AH-0.5L
06972249260887HH-HHN-AH-0.25L
06972249260870HH-HHN-AW-6L
06972249260863HH-HHN-AW-5L
06972249260856HH-HHN-AW-4L
06972249260849HH-HHN-AW-3L
06972249260832HH-HHN-AW-2L
06972249260825HH-HHN-AW-1L
06972249260818HH-HHN-AW-0.5L
06972249260801HH-HHN-AW-0.25L
06972249260795HH-HHN-BT-6L
06972249260788HH-HHN-BT-5L

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.