Disposable PEEP valve with converter 4000-PVC

GUDID B0024000PVC0

Disposable PEEP valve with converter to be used with manual resuscitators.

B.L.S. Systems Limited

PEEP valve, single-use
Primary Device IDB0024000PVC0
NIH Device Record Key2f9714d0-ee5d-46ac-966f-f7551581b1ae
Commercial Distribution StatusIn Commercial Distribution
Brand NameDisposable PEEP valve with converter
Version Model Number4000-PVC
Catalog Number4000-PVC
Company DUNS200103823
Company NameB.L.S. Systems Limited
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone905 339 1069
Emailtedreesor@blssystemsltd.com
Phone905 339 1069
Emailtedreesor@blssystemsltd.com

Operating and Storage Conditions

Storage Environment TemperatureBetween -40 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB0024000PVC0 [Primary]
HIBCCB0024000PVC2 [Package]
Package: bag [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BYEAttachment, Breathing, Positive End Expiratory Pressure

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-07-06
Device Publish Date2017-02-13

Devices Manufactured by B.L.S. Systems Limited

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