FDA.report

Provox Life BasePlate Adaptor

Primary DI
07331791015342
Brand
Provox Life BasePlate Adaptor
Company
Atos Medical AB
Model
8057
Catalog number
8057
Device description
Provox Life BasePlate Adaptor is an accessory that allows attaching and detaching medical devices, e.g. an HME, with an ISO 15 mm standard connector to a Provox Life attachment. The adaptor is intended for single patient reuse.
Published
2022-07-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
BYDCondenser, Heat And Moisture (Artificial Nose)

Product Code Classifications

CodeDeviceSpecialtyClass
BYDCondenser, Heat And Moisture (Artificial Nose)Anesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07331791015342PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07331791015342073317910153427331791015342

GMDN Terms

TermDefinition
Tracheostoma protective filterA non-sterile device designed as a filter for protecting a stomal opening in the windpipe (surgically-created artificial opening between the trachea and the body surface through which the patient can breathe) against harmful external influences. It may also function as a heat & moisture exchanger (HME) intended to capture the patient's exhaled breath so that it can be used to warm and moisten inspired air to help keep the trachea lubricated and prevent its mucosa from drying. It is typically designed as a hydrophobic foam filter of various sizes held in place with an adhesive strip. This is a single-use device changed regularly according to the manufacturer's instructions.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Keep away from rain. Keep away from sunlight.
Special Storage Condition, Specify00Keep dry. Keep away from sunlight.
Storage Environment Temperature2 Degrees Celsius42 Degrees Celsius
Storage Environment Temperature36 Degrees Fahrenheit108 Degrees Fahrenheit

Sterilization Methods

Method

Contacts

PhoneEmail
+4641519800info@atosmedical.com

Regulatory Flags

DUNS number
355470923
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
07331791181238Provox Life Comfort Adhesive Oval840384032026-01-16
07331791181276Provox Life Comfort Experience Oval809480942026-01-16
07331791181153Provox Life Oxygen (10 pcs)762076202025-12-16
07331791181160Provox Life Oxygen (30 pcs)762176212025-12-16
07331791181177Provox Dilator 17834283422025-07-01
07331791181184Provox Dilator 20834383432025-07-01
07331791181191Provox Dilator834183412025-02-08
07331791016905Provox Adhesive OptiDerm Round725572552022-07-13
07331791016929Provox XtraBase Adhesive726572652022-07-13
07331791016899Provox Adhesive FlexiDerm Plus733173312022-07-13
07331791016912Provox Adhesive OptiDerm Plus733273322022-07-13
07331791016943Provox Life Go HME831083102022-12-07
07331791016950Provox Life Home HME831183112022-12-07
07331791016967Provox Life Energy HME831283122022-12-07
07331791016974Provox Life Protect HME831383132022-12-07
07331791017124Freevent XtraCare Mini Blue (30 pcs)800580052023-12-04
07331791017131Freevent XtraCare Mini Pink (30 pcs)800680062023-12-04
07331791017148Freevent XtraCare Mini White (5 pcs)800880082023-12-04
07331791017155Freevent O2 Adaptor Mini (10 pcs)800780072023-12-04
07331791017001Provox Life Standard Experience Round806580652022-11-29

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
08904428798421OSSEOUS- ShowerProtectEON MEDITECH PRIVATE LIMITEDBYD2026-03-13
08904428798292OSSEOUS- TouchFree HME Series - StandardEON MEDITECH PRIVATE LIMITEDBYD2026-03-13
08906039318012OSSEOUS-Heat Moisture Exchanger-AirEON MEDITECH PRIVATE LIMITEDBYD2026-03-13
44710810101913N/AGALEMED CORPORATIONBYD2026-03-04
04710810101939N/AGALEMED CORPORATIONBYD2026-03-04
00810050855815ThermoFlo®TYPENEX MEDICAL LLCBYD2026-01-26
07331791181153Provox Life Oxygen (10 pcs)Atos Medical ABBYD2025-12-16
07331791181160Provox Life Oxygen (30 pcs)Atos Medical ABBYD2025-12-16
10848530107281Heat Moisture ExchangerSUNSET HEALTHCARE SOLUTIONS, INC.BYD2025-08-19
34026704928935GIBECKTELEFLEX INCORPORATEDBYD2025-08-18
34026704928942GIBECKTELEFLEX INCORPORATEDBYD2025-08-18
34026704928959GIBECKTELEFLEX INCORPORATEDBYD2025-08-18
34026704928966GIBECKTELEFLEX INCORPORATEDBYD2025-08-18
34026704928973GIBECKTELEFLEX INCORPORATEDBYD2025-08-18
34026704928980GIBECKTELEFLEX INCORPORATEDBYD2025-08-18
34026704927457GIBECKTELEFLEX INCORPORATEDBYD2025-07-31
24026704927467GIBECKTELEFLEX INCORPORATEDBYD2025-07-31
24026704927740GIBECKTELEFLEX INCORPORATEDBYD2025-07-31
24026704929010GIBECKTELEFLEX INCORPORATEDBYD2025-07-31
34026704929024GIBECKTELEFLEX INCORPORATEDBYD2025-07-31
34026704929031GIBECKTELEFLEX INCORPORATEDBYD2025-07-31
24026704929492GIBECKTELEFLEX INCORPORATEDBYD2025-07-31
24026704929522GIBECKTELEFLEX INCORPORATEDBYD2025-07-31
34026704929536GIBECKTELEFLEX INCORPORATEDBYD2025-07-31
24026704929720GIBECKTELEFLEX INCORPORATEDBYD2025-07-31
34026704929864GIBECKTELEFLEX INCORPORATEDBYD2025-07-31
24026704929041GIBECKTELEFLEX INCORPORATEDBYD2025-07-30
20884389976064MEDLINEMEDLINE INDUSTRIES, INC.BYD2025-07-16
00848253003948TruFit™ Adhesive Housing, 30 PackFreudenberg Medical, LLCBYD2025-04-01
00848253003931TruFit™ Adhesive Housing, 6 PackFreudenberg Medical, LLCBYD2025-04-01