DEVICE: V-Vac starter kit (07045430014930)
Device Identifier (DI) Information
V-Vac starter kit
985000
Not in Commercial Distribution
985000
Laerdal Medical AS
985000
Not in Commercial Distribution
985000
Laerdal Medical AS
The V-Vac Suction Unit is a manual portable unit designed to provide quick and effective suction. Fully assembled, it weighs less than one pound (0,45 kg) and can be adjusted to accomodate different hand sizes or to provide a range of suction pressures from no more than ~170mmHg up to ~380mmHg.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No | |
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? |
---|---|---|---|---|
47368 | Emergency airway clearance suction system, manual |
A portable assembly of devices, which includes an orally-introduced handpiece/tip, intended to manually aspirate unwanted materials (e.g., fluids, secretions) from the airway typically during patient transport or an emergency situation (e.g., placed on a crash cart). In addition to the handpiece/tip, it includes a manually-powered (hand or foot-operated) suction pump, a collection container, and typically microbial/hydrophobic filters. The system is not intended for surgical use.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
BTA | Pump, Portable, Aspiration (Manual Or Powered) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K862875 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Humidity: between 10 and 95 Percent (%) Relative Humidity |
Storage Environment Temperature: between -40 and 63 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
c26f017d-bf20-4099-8e45-053d0f742cf0
March 20, 2024
6
September 24, 2016
March 20, 2024
6
September 24, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
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
[?]
(800)4311055
customerservice@laerdal.com
customerservice@laerdal.com