FDA.reportPublic FDA data

Disposable Mouthpiece 22mm OD

Primary DI
00850644007206
Brand
Disposable Mouthpiece 22mm OD
Company
Vacumed
Model
1021-100
Catalog number
1021-100
Device description
cardboard mouthpiece
Published
2018-08-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
00850644007206PrimaryGS10
08506440072062Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850644007206008506440072068506440072060850644007206
08506440072062085064400720628506440072062

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
100
Premarket exempt
true
Lot or batch
true
Contains 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
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
00850644007374Disposable Mouthpiece 35mm OD1027-BULK1027-BULK2018-08-17

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06420099000332703417 Disposable Flow Transducer QTY 4Medikro OyBYP2026-04-21
06420099000622M9242-SP-90, SpiroSafe Disposable Flow TransducerMedikro OyBYP2026-04-21
08904461055031OSSEOUS-SnorOFFEON MEDITECH PRIVATE LIMITEDBYP2026-03-13
08904461055024OSSEOUS-SnorOFFEON MEDITECH PRIVATE LIMITEDBYP2026-03-13
06923980103674N/AGaleMed Xiamen Co., Ltd.BYP2025-12-23
46923980103672N/AGaleMed Xiamen Co., Ltd.BYP2025-12-23
10197344011315HUDSON RCIMEDLINE INDUSTRIES, INC.BYP2025-08-18
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10889483569160AirLife™AIRLIFEBYP2025-03-18
10889483569191AirLife™AIRLIFEBYP2025-03-18
00817081028225Mouthpiece, Disposable, White, Thermoplastic, Bite Block StyleA-M SYSTEMS, LLCBYP2025-02-21
00817081028249Breathebite Mouthpiece, Disposable, Thermoplastic, Tongue DepressingA-M SYSTEMS, LLCBYP2025-02-21
07613365500127SpiroDefGanshorn Medizin Electronic GmbHBYP2024-12-20
07613365500141SpiroDefGanshorn Medizin Electronic GmbHBYP2024-12-20
07613365500202SpiroDefGanshorn Medizin Electronic GmbHBYP2024-12-20
20197344120342HUDSON RCIMEDLINE INDUSTRIES, INC.BYP2024-12-10
04719873130191Aerogen®GoHCMED INNOVATIONS CO., LTD.BYP2024-08-20
20197344103734MEDLINEMEDLINE INDUSTRIES, INC.BYP2024-07-22
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