FDA.reportPublic FDA data

Tri-Seal mouthseal with mouthpiece

Primary DI
00850644007589
Brand
Tri-Seal mouthseal with mouthpiece
Company
Vacumed
Model
1007-MP
Catalog number
1007-MP
Device description
blue vinyl, 22mm OD, 50/bx
Published
2018-10-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
BYPMOUTHPIECE, BREATHING

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYPMouthpiece, BreathingAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850644007589PrimaryGS10
08506440075896Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850644007589008506440075898506440075890850644007589
08506440075896085064400758968506440075896

GMDN Terms#

Term, Definition table
TermDefinition
Breathing mouthpiece, single-useA device designed to be inserted into a patient's mouth to facilitate access to the respiratory system. It is typically a small rigid or semi-rigid plastic hollow device with a shape and structure that provides an appropriate gastight seal (i.e., with a patient's lips) and prevents collapse. It is typically attached, either directly or through other tubes/adaptors, to diagnostic and/or therapeutic respiratory devices (e.g., ventilator, inhaler, incentive spirometer, aerosol equipment, breath analyser, breath collector). This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)235-3333info@vacumed.com

Regulatory Flags#

DUNS number
077967081
Device count
50
Premarket exempt
true
Combination product
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850644007008Gold Edition Carbon Dioxide Analyzer17515175152016-09-14
00850644007169Disposable Mouthpiece 19mm OD1020-2501020-2502018-08-17
00850644007176Disposable Mouthpiece 19mm OD1020-1001020-1002018-08-17
00850644007206Disposable Mouthpiece 22mm OD1021-1001021-1002018-08-17
00850644007213Disposable Mouthpiece 22mm OD1021-2501021-2502018-08-24
00850644007220Disposable Mouthpiece 35mm OD1027-1001027-1002018-08-24
00850644007237Disposable Mouthpiece 35mm OD1027-2501027-2502018-08-24
00850644007244Disposable Mouthpiece 35mm OD1026-1001026-1002018-08-24
00850644007251Disposable Mouthpiece 35mm OD1026-2501026-2502018-08-24
00850644007268Disposable Mouthpiece 30mm OD1025-1001025-1002018-08-17
00850644007275Disposable Mouthpiece 30mm OD1025-2501025-2502018-08-24
00850644007282Disposable Mouthpiece 29mm OD1024-1001024-1002018-08-24
00850644007299Disposable Mouthpiece 29mm OD1024-2501024-2502018-08-24
00850644007305Pediatric mouthpiece 100/bx1004-BULK1004-BULK2018-08-24
00850644007312Disposable Mouthpiece 27mm OD1023-2501023-2502018-08-24
00850644007329Disposable Mouthpiece 26mm OD1022-1001022-1002018-08-24
00850644007336Disposable Mouthpiece 26mm OD1022-2501022-2502018-08-24
00850644007343Snuffer noseclip 100/bx100810082018-08-24
00850644007350Disposable Mouthpiece 22mm OD1021-BULK1021-BULK2018-08-17
00850644007367Disposable Mouthpiece 19mm OD1020-BULK1020-BULK2018-08-17

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Primary DI, Brand, Company table
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