FDA.report

Swivel Adaptor

Primary DI
00850068303076
Brand
Swivel Adaptor
Company
Remsleep Holdings, Inc.
Model
8007
Published
2025-08-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
BZDVentilator, Non-Continuous (Respirator)

Product Code Classifications

CodeDeviceSpecialtyClass
BZDVentilator, Non-Continuous (Respirator)Anesthesiology2

Premarket Submissions

SubmissionSupplement
K233415000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K233415000DELTAWAVE Nasal Pillows SystemRemsleep Holdings2024-07-02BZD

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00850068303076PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00850068303076008500683030768500683030760850068303076

GMDN Terms

TermDefinition
CPAP/BPAP nasal mask, reusableA flexible, form-shaped device designed to be placed over a user's nose to interface with a continuous positive airway pressure (CPAP) or bi-level positive airway pressure (BPAP) unit to provide the respiratory tract with direct ambient air, or medical oxygen (O2) and air, at a higher pressure than ambient air for noninvasive positive pressure ventilation (NPPV). It is typically made of plastic and/or silicone materials that create an airtight seal around the nose. It is available in various designs and sizes and stabilized with a headstrap. This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
117062644
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
false
Expiration date on label
false
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
00850068303007DeltaWave Nasal Pillow System80002025-08-27
00850068303014Nasal Cannula80012025-08-27
00850068303021Nasal Cannula 80022025-08-27
00850068303038Nasal Cannula80032025-08-27
00850068303045Hose assembly80042025-08-27
00850068303052Head strap80052025-08-27
00850068303069Angled Adaptor80062025-08-27
00850068303083DeltaWaveDeltaWave2025-08-27

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44710810109643N/AGALEMED CORPORATIONBZD2026-03-05
44710810109650N/AGALEMED CORPORATIONBZD2026-03-05
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