FDA.reportPublic FDA data

HME

Primary DI
00850003157061
Brand
HME
Company
BLEEP, LLC
Model
100592
Device description
HME Starter Bundle
Published
2022-08-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BZDVentilator, Non-Continuous (Respirator)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZDVentilator, Non-Continuous (Respirator)Anesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172335000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172335000Bleep DreamPortSnapcpap2018-03-30BZD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850003157061PrimaryGS10
10850003157068Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850003157061008500031570618500031570610850003157061
1085000315706810850003157068

GMDN Terms#

Term, Definition table
TermDefinition
Home CPAP unitA portable, mains electricity (AC-powered) device, which may include rechargeable batteries, intended to assist noninvasive ventilation (i.e., without use of an artificial airway) using continuous positive airway pressure (CPAP) during spontaneous respiration, primarily to treat adult patients affected by obstructive sleep apnoea (OSA); it may also be intended to treat snoring. It is a small desktop unit with controls, and may include a built-in humidifier; the airway pressure may be automatically adjusted to help provide optimal CPAP through use of a sensor (auto CPAP). The device is intended for use in the home but may also be used in healthcare facilities.

Contacts#

Phone, Email table
PhoneEmail
1-833-392-5337info@bleepeep.com

Regulatory Flags#

DUNS number
081909526
Device count
16
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850003157214Eclipse Vent Filter100671 2023-08-21
00850003157207Eclipse Vent Diffuser Kit100668 2023-08-21
10850003157211Eclipse Vent Filter100671 2023-08-21
00850003157177Eclipse Vent Diffuser Kit1006612022-10-11
00850003157184Eclipse Vent Filter Replacement Pack1006622022-10-11
10850003157174Eclipse Vent Diffuser Kit1006612022-10-11
10850003157181Eclipse Vent Filter Replacement Pack1006622022-10-11
00850003157191Eclipse Magnetic Port Replacement Pack1006592022-10-11
00850003157085Vent filter 24 pack1005952022-08-23
00850003157092Vent diffuser kit 24 pack1006052022-08-23
00850003157115Bleep Halos1005902022-08-23
00850003157122Eclipse Starter Kit1005892022-08-23
00850003157047Bleep Dreamway 1003802022-08-23
10850003157068HME1005922022-08-23
00850003157078Vent diffuser kit - Quarterly supply1005932022-08-23
10850003157082Vent filter 24 pack1005952022-08-23
10850003157099Vent diffuser kit 24 pack1006052022-08-23
00850003157108Vent Diffuser kit1006042022-08-23
20850003157119Bleep Halos1005902022-08-23
10850003157129Eclipse Starter Kit1005892022-08-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09420012464668Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBZD2026-03-19
09420012423573Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBZD2026-03-18
09420012425034Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBZD2026-03-18
09420012425041Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBZD2026-03-18
09420012448446Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBZD2026-03-18
09420012448514Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBZD2026-03-18
09420012448521Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBZD2026-03-18
09420012448736Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBZD2026-03-18
09420012456434Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBZD2026-03-18
09420012464644Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBZD2026-03-18
09420012464682Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBZD2026-03-18
04719893347272WellellWellell Inc.BZD2026-03-17
09420012461629F&P ViteraFISHER & PAYKEL HEALTHCARE LIMITEDBZD2026-01-27
09420012472212NovaFISHER & PAYKEL HEALTHCARE LIMITEDBZD2025-09-15
09420012472229NovaFISHER & PAYKEL HEALTHCARE LIMITEDBZD2025-09-15
09420012472236NovaFISHER & PAYKEL HEALTHCARE LIMITEDBZD2025-09-15
09420012472243NovaFISHER & PAYKEL HEALTHCARE LIMITEDBZD2025-09-15
09420012472366NovaFISHER & PAYKEL HEALTHCARE LIMITEDBZD2025-09-15
09420012472373NovaFISHER & PAYKEL HEALTHCARE LIMITEDBZD2025-09-15
09420012472380NovaFISHER & PAYKEL HEALTHCARE LIMITEDBZD2025-09-15
09420012472397NovaFISHER & PAYKEL HEALTHCARE LIMITEDBZD2025-09-15
08056814676223DIMARHMC PREMEDICAL SPABZD2025-03-20
08056814676247DIMARHMC PREMEDICAL SPABZD2025-03-20
08056814676254DIMARHMC PREMEDICAL SPABZD2025-03-20
08056814676261DIMARHMC PREMEDICAL SPABZD2025-03-20
08056814676377DIMARHMC PREMEDICAL SPABZD2025-03-20
08056814676384DIMARHMC PREMEDICAL SPABZD2025-03-20
08056814676391DIMARHMC PREMEDICAL SPABZD2025-03-20
08056814676407DIMARHMC PREMEDICAL SPABZD2025-03-20
08056814676230DIMARHMC PREMEDICAL SPABZD2025-03-20