DEVICE: Rescuer BVM Manual Resuscitator (B00240000)
Device Identifier (DI) Information
Rescuer BVM Manual Resuscitator
4000
In Commercial Distribution
4000
B.L.S. Systems Limited
4000
In Commercial Distribution
4000
B.L.S. Systems Limited
Rescuer adult disposable manual resuscitator with 2900 mL reservoir bag, #5 cushion mask and 2 m crush proof oxygen tubing (Single Unit)
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
36086 | Pulmonary resuscitator, manual, single-use |
A non-sterile, hand-operated device designed to provide or assist ventilation in patients who are apnoeic or exhibit inadequate respiration. It typically employs entrained ambient air and includes a large flexible chamber that is hand-ventilated, a gas reservoir, tubing, and a connector for attachment to a mask or endotracheal (ET) tube; oxygen (O2) from an O2 source may also be connected when necessary. It is used used by emergency medical services (EMS) in ambulances, intensive care units (ICU), during internal patient transfer, accident and emergency (A&E), mass casualty incidents (MCI), and is generally placed strategically throughout a hospital. This is a single-use device.
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FDA Product Code
[?]Product Code | Product Code Name |
---|---|
BTM | Ventilator, Emergency, Manual (Resuscitator) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K993194 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between -40 and 60 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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Device Size Text, specify: Adult |
Device Record Status
8db87435-dc0c-439f-907e-cd270fab34e3
July 06, 2018
4
May 07, 2015
July 06, 2018
4
May 07, 2015
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
B00240006 | 30 | B00240000 | In Commercial Distribution | Case of 30 | |
B00240001 | 6 | B00240000 | In Commercial Distribution | Case of 6 |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
9053391069
tedreesor@blssystemsltd.com
tedreesor@blssystemsltd.com