FDA.reportPublic FDA data

QUAKE

Primary DI
10383480000065
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
OTC
false
Sterile
false
Single use
false

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
Mechanical positive pressure airway secretion-clearing deviceA hand-held, mechanical device designed to remove excessive mucus or sputum (phlegm) from the lungs and upper airway of a patient typically suffering from acute or chronic lung disease. A positive expiratory pressure (PEP) is created when a patient exhales into the device, typically causing a high-density stainless steel ball to rapidly fluctuate up and down to create vibrations in the chest wall which loosens the mucus for expectoration and also assists 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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
626238844
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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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
00383480000068QUAKE129712972016-09-21
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

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Primary DI, Brand, Company table
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00841470100858PercussorPULMODYNE INCBYI2026-05-29
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