FDA.reportPublic FDA data

Kricket

Primary DI
00850085243027
Brand
Kricket
Company
Sleepres, LLC
Model
SR-00007
Catalog number
SR-00007
Device description
Standard 15mm Tube
Published
2026-10-13
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

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
K251770000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K251770000SleepRes PAP SystemSleepres, Inc.2025-12-15BZD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850085243027PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850085243027008500852430278500852430270850085243027

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.

Regulatory Flags#

DUNS number
047606875
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850085243003KricketSR-00005SR-000052026-10-13
00850085243010KricketSR-00006SR-000062026-10-13
00850085243034KricketSR-00008SR-000082026-10-13
00850085243041KricketSR-00009SR-000092026-10-13
00860008554369KricketSR-00001SR-000012026-10-13
00860008554376KricketSR-00002SR-000022026-10-13
00860008554383KricketSR-00003SR-000032026-10-13
00860008554390KricketSR-00004SR-000042026-10-13
00860008554307V-Com10042023-02-28
10860008554304V-Com10042023-02-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06948538347737Alto Nasal Pillows InterfaceBMC Medical Co., Ltd.BZD2026-10-15
06948538347744Alto Nasal Pillows InterfaceBMC Medical Co., Ltd.BZD2026-10-15
06948538347751Alto Nasal Pillows InterfaceBMC Medical Co., Ltd.BZD2026-10-15
06948538347768Alto Nasal Pillows InterfaceBMC Medical Co., Ltd.BZD2026-10-15
06948538347775Alto Nasal Pillows InterfaceBMC Medical Co., Ltd.BZD2026-10-15
06948538347782Alto Nasal Pillows InterfaceBMC Medical Co., Ltd.BZD2026-10-15
06948538347799Alto Nasal Pillows InterfaceBMC Medical Co., Ltd.BZD2026-10-15
06948538347805Alto Nasal Pillows InterfaceBMC Medical Co., Ltd.BZD2026-10-15
06948538347812Alto Nasal Pillows InterfaceBMC Medical Co., Ltd.BZD2026-10-15
06948538347829Alto Nasal Pillows InterfaceBMC Medical Co., Ltd.BZD2026-10-15
06948538347836Alto Full Face MaskBMC Medical Co., Ltd.BZD2026-10-15
06948538347843Alto Full Face MaskBMC Medical Co., Ltd.BZD2026-10-15
06948538347850Alto Full Face MaskBMC Medical Co., Ltd.BZD2026-10-15
06948538347867Alto Full Face MaskBMC Medical Co., Ltd.BZD2026-10-15
06948538347874Alto Full Face MaskBMC Medical Co., Ltd.BZD2026-10-15
06948538347881Alto Full Face MaskBMC Medical Co., Ltd.BZD2026-10-15
06948538347898Alto Full Face MaskBMC Medical Co., Ltd.BZD2026-10-15
06948538347904Alto Full Face MaskBMC Medical Co., Ltd.BZD2026-10-15
06948538347911Alto Full Face MaskBMC Medical Co., Ltd.BZD2026-10-15
06948538347928Alto Full Face MaskBMC Medical Co., Ltd.BZD2026-10-15
06948538347935Alto Full Face MaskBMC Medical Co., Ltd.BZD2026-10-15
06948538347942Alto Full Face MaskBMC Medical Co., Ltd.BZD2026-10-15
06948538347959Alto Full Face MaskBMC Medical Co., Ltd.BZD2026-10-15
06948538347966Alto Full Face MaskBMC Medical Co., Ltd.BZD2026-10-15
06948538347973Alto Full Face MaskBMC Medical Co., Ltd.BZD2026-10-15