FDA.reportPublic FDA data

QUAKE

Primary DI
00383480000068
Brand
QUAKE
Company
THAYER MEDICAL CORPORATION
Model
1297
Catalog number
1297
Device description
QUAKE VIBRATORY PEP DEVICE
Published
2016-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BYIPercussor, Powered-Electric

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYIPercussor, Powered-ElectricAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K974849000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K974849000X-AIR-CISERHougen Mfg., Inc.1998-08-06BYI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10383480000065PackageGS15In Commercial Distribution
00383480000068PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1038348000006510383480000065
00383480000068003834800000683834800000680383480000068

GMDN Terms#

Term, Definition table
TermDefinition
Positive pressure airway secretion-clearing deviceA hand-held, non-powered device designed to remove excessive mucus or sputum (phlegm) from the lungs and upper airways using positive pressure airway (PEP) to treat patients affected by acute or chronic lung disease. PEP is created when a patient exhales into the device which creates vibrations in the chest by various means (e.g., an oscillating ball or creating bubbles in a solution within the device) loosening the mucus for expectoration and assisting in lung expansion. Also known as an oscillating positive expiratory pressure (OPEP) device, it is a single-patient device designed for use both in a healthcare facility and in the home. This is a reusable device.

Contacts#

Phone, Email table
PhoneEmail
1-800-250-3330INFO@THAYERMEDICAL.COM

Regulatory Flags#

DUNS number
626238844
Device count
1
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00383480000204SINGLE SPRAY MDI ADAPTER102110212016-09-21
00383480000181SINGLE SPRAY MDI ADAPTER102010202016-09-21
00383480000594LiteAire BASIC180318032024-09-11
00383480000006LITEAIRE13031303, 1304, 13062023-05-09
10383480000003LITEAIRE13031303, 1304, 13062023-05-09
00383480000020VALVED TEE ADAPTER108810882018-09-14
00383480000037VALVED TEE ADAPTER100910092018-09-14
00383480000044VALVED TEE ADAPTER108510852018-09-14
00383480000075MEDLINE VALVED TEE ADAPTERHCSA1008HCSA10082018-09-14
00383480000082MEDLINE VALVED TEE ADAPTERHCSA1009HCSA10092018-09-14
00383480000013VALVED TEE ADAPTER100810082018-09-14
00383480000495LITEAIRE13031303, 1304, 13062016-09-21
40383480000493LITEAIRE13031303, 1304, 13062016-09-21
10383480000027VALVED TEE ADAPTER108810882018-09-14
10383480000034VALVED TEE ADAPTER100910092018-09-14
10383480000041VALVED TEE ADAPTER108510852018-09-14
10383480000072MEDLINE VALVED TEE ADAPTERHCSA1008HCSA10082018-09-14
10383480000089MEDLINE VALVED TEE ADAPTERHCSA1009HCSA10092018-09-14
00383480000051PRIMEAIRE111411142016-09-21
10383480000065QUAKE129712972016-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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00841470100858PercussorPULMODYNE INCBYI2026-05-29
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00816305025262AffloVestTactile Systems Technology, Inc.BYI2026-05-27
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