FDA.reportPublic FDA data

ShurClear

Primary DI
10641043370025
Brand
ShurClear
Company
MERCURY ENTERPRISES, INC.
Model
IS-37002
Published
2018-04-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
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
K121587000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121587000BREATH SHAKECheen Houng Ent. Co. , Ltd.2013-11-22BYI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10641043370025PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1064104337002510641043370025

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
(727) 573-0088hospitalcustomerservice@mercurymed.com

Regulatory Flags#

DUNS number
032705659
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10641043508473Neo-Tee T-Piece Resuscitator10-508232026-03-26
10641043563311CPR-2 Bag10-563312026-02-12
10641043564608CPR-2 Bag10-564602025-12-16
30641043564602CPR-2 Bag10-564602025-12-16
10641043320006EZflow10-320002016-03-07
10641043320013EZflow10-320012016-03-07
10641043320020EZflow10-320022016-03-09
10641043320037EZflow MAX10-320032016-03-09
10641043320044EZflow MAX10-320042016-03-09
10641043320051EZflow10-320052016-03-09
10641043320068EZflow10-320062016-03-09
10641043320099EZflow MAX10-320092016-03-09
10641043588727Hyperinflation System10-588722025-09-11
10641043566039CPR-2 Bag10-566032025-07-15
30641043566033CPR-2 Bag10-566032025-07-15
10641043913161Neo-Tee T-Piece Resuscitator CircuitM1091316VSM1091316VS2024-02-08
10641043913352Neo-Tee T-Piece Resuscitator CircuitM1091335VSM1091335VS2024-02-08
10641043913659Neo-Tee T-Piece Resuscitator CircuitM1091365VSM1091365VS2024-02-08
10641043553701StatCO2 End Tidal CO2 Detector10-553702016-01-08
30641043913165Neo-Tee T-Piece Resuscitator Circuit10-913162024-02-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841470100841PercussorPULMODYNE INCBYI2026-05-29
00841470100858PercussorPULMODYNE INCBYI2026-05-29
00816305024890AffloVestTactile Systems Technology, Inc.BYI2026-05-27
00816305024906AffloVestTactile Systems Technology, Inc.BYI2026-05-27
00816305024913AffloVestTactile Systems Technology, Inc.BYI2026-05-27
00816305024920AffloVestTactile Systems Technology, Inc.BYI2026-05-27
00816305024937AffloVestTactile Systems Technology, Inc.BYI2026-05-27
00816305025101AffloVestTactile Systems Technology, Inc.BYI2026-05-27
00816305025248AffloVestTactile Systems Technology, Inc.BYI2026-05-27
00816305025255AffloVestTactile Systems Technology, Inc.BYI2026-05-27
00816305025262AffloVestTactile Systems Technology, Inc.BYI2026-05-27
00816305025279AffloVestTactile Systems Technology, Inc.BYI2026-05-27
00816305025286AffloVestTactile Systems Technology, Inc.BYI2026-05-27
10889483563113BALLARD™SUNMED, LLCBYI2025-12-01
30889483563117BALLARD™SUNMED, LLCBYI2025-12-01
00606959420540inCourage®Respiratory Technologies, Inc.BYI2025-09-17
00606959420557inCourage®Respiratory Technologies, Inc.BYI2025-09-17
00606959420564inCourage®Respiratory Technologies, Inc.BYI2025-09-17
00606959420571inCourage®Respiratory Technologies, Inc.BYI2025-09-17
B102090700S0100SmartVestELECTROMED, INC.BYI2025-07-02
07290020062000LibAirty Airway Clearance SystemSYNCHRONY MEDICAL LTDBYI2025-05-19
07290020062017LibAirty Airway Clearance System Vest (S)SYNCHRONY MEDICAL LTDBYI2025-05-19
07290020062024LibAirty Airway Clearance System Vest (M)SYNCHRONY MEDICAL LTDBYI2025-05-19
07290020062031LibAirty Airway Clearance System Vest (L)SYNCHRONY MEDICAL LTDBYI2025-05-19
B102125003S0110SmartVestELECTROMED, INC.BYI2025-03-19
B102125003S0311SmartVestELECTROMED, INC.BYI2025-01-21
B102125003S0411SmartVestELECTROMED, INC.BYI2025-01-21
00887761976849The Vest®SystemHILL-ROM SERVICES PTE. LTD.BYI2024-12-20
00887761967243The Vest APX SystemHILL-ROM SERVICES PTE. LTD.BYI2024-09-06
00887761967366The Vest APX SystemHILL-ROM SERVICES PTE. LTD.BYI2024-09-06