VOCSN External Bacterial Filter

Primary DI
00855573007198
Brand
VOCSN External Bacterial Filter
Company
VENTEC LIFE SYSTEMS, INC.
Model
PRT-00790-001
Catalog number
PRT-00790-002
Device description
VOCSN External Bacterial Filter
Published
2017-11-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
CAHFilter, Bacterial, Breathing-Circuit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CAHFilter, Bacterial, Breathing-CircuitAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K162877000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162877000VOCSN Unified Respiratory SystemVentec Life Systems, Inc.2017-04-07CBK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00855573007198PackageGS110In Commercial Distribution
00855573007013PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00855573007198008555730071988555730071980855573007198
00855573007013008555730070138555730070130855573007013

GMDN Terms#

Term, Definition table
TermDefinition
In-exsufflatorA portable, pneumatic, device that, through a rapid shift in pressure via a face mask, produces a high expiratory flow rate from the lungs, simulating a cough. This technique is referred to as EWNP (exsufflation with negative pressure) or mechanical insufflation-exsufflation. This device is suitable for any patient with an ineffective cough due to, e.g., muscular disorders or paralysis and would typically be used to clear retained broncho-pulmonary secretions, reducing the risk of respiratory complications.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
078758082
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850018761048VOCSN Patient Breathing PackageAdult, Active, Oxygen, BluePRT-00794-00X2020-10-07
00850018761062VOCSN Patient Breathing PackageAdult, Active, Heated, Oxygen, BluePRT-00798-00X2020-10-07
00850018761116VOCSNV+C, JapanesePRT-01098-1XX2021-02-23
00855573007013VOCSN External Bacterial FilterPRT-00790-001PRT-00790-0032017-11-11
00855573007037VOCSN Patient Breathing PackageAdult, Active, Oxygen, BluePRT-00794-0012017-11-11
00855573007044VOCSN Patient Breathing PackageAdult, Passive, Oxygen, BluePRT-00793-0012017-11-11
00855573007075VOCSN Patient Breathing PackageAdult, Passive, BluePRT-00792-0012019-01-30
00855573007082VOCSN Patient Breathing PackageAdult, Active, Heated, BluePRT-00795-0012019-01-30
00855573007099VOCSN Patient Breathing Package Adult, Passive, Heated, BluePRT-00796-0012019-01-30
00855573007105VOCSN Nurse Call CableNormally ClosedPRT-00820-0012017-11-11
00855573007112VOCSN Nurse Call CableNormally OpenPRT-00821-0012017-11-11
00855573007129VOCSN Travel Suction CanisterPRT-00824-000PRT-00824-0012017-11-11
00855573007181VOCSN Patient Breathing PackagePediatric, Valveless, BluePRT-00927-0012019-01-30
00855573007228VOCSN Patient Breathing PackageAdult, Valveless, BluePRT-00926-0012019-01-30
00855573007235VOCSN Patient Breathing PackageAdult, Valveless, Heated, BluePRT-00928-0012019-01-30
00855573007341VOCSN Patient Breathing PackagePediatric, Valveless, Heated, BluePRT-00929-0012019-01-30
00855573007549VOCSN Patient Breathing PackagePediatric, Active, BluePRT-00799-0012018-07-10
00855573007563VOCSN Patient Breathing PackagePediatric, Active, Heated, BluePRT-00803-0012018-07-11
00855573007587VOCSN Patient Breathing PackagePediatric, Active, Oxygen, BluePRT-00802-0012018-07-11
00855573007600VOCSN Patient Breathing PackagePediatric, Active, Heated, Oxygen, BluePRT-00806-0012018-07-11

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