FDA.reportPublic FDA data

Healthline Medical Inc. - Medicator Maximixer+Plus-Accessories

Primary DI
00850022357046
Brand
Healthline Medical Inc. - Medicator Maximixer+Plus-Accessories
Company
Medi/Nuclear Corporation, Inc.
Model
AM-608A
Device description
Mask, Portless Kit Filtered Adult
Published
2020-11-09
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
BSJMask, Gas, Anesthetic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BSJMask, Gas, AnestheticAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850022357480PackageGS110In Commercial Distribution
00850022357046PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850022357480008500223574808500223574800850022357480
00850022357046008500223570468500223570460850022357046

GMDN Terms#

Term, Definition table
TermDefinition
Aerosol face mask, rebreathing, single-useA flexible, form-shaped device that is placed over the nose and mouth to deliver aerosolized particles/gases to a patient's airway. It is typically used in conjunction with a nebulizer or medicine chamber spacer for the delivery of medication in either a healthcare or home setting. It is made of high-grade resins or other materials to produce a soft, flexible mask that will create an airtight seal against the patient's face. It may include a headstrap and is available in a range of sizes. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00store at room temperature

Contacts#

Phone, Email table
PhoneEmail
800-321-5981cs@medinuclear.com

Regulatory Flags#

DUNS number
079628327
Device count
1
Premarket exempt
true
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
00850022357817Xenon MasterMN00282024-09-10
00850022357824Xenon MasterMN00382024-09-10
00850022357831Xenon MasterMN00402024-09-10
00850022357848Xenon MasterMN04092024-09-10
00850022357855Xenon MasterMN04122024-09-10
00850022357176N/AMN00392020-11-09
00850022357152N/AMN00022020-11-09
00857863007468Aero/Vent PlusMN50452017-06-09
00857863007475Aero/Vent PlusMN71102017-06-09
00850022357787Insta/Vent, Insta/Vent Plus, MedicatorMN12132023-12-07
00850022357770Xenon Master Administration SetMN2892M2023-12-07
10850022357784Insta/Vent, Insta/Vent Plus, MedicatorMN12132023-12-07
00850022357794Xenon MasterMN27722023-12-07
00850022357800Xenon MasterMN27732023-12-07
00850022357701Insta/Vent - Safe-T-Shield MouthpieceMNMP500-NC2022-04-18
00857863007857N/AMN2550B2017-06-09
00857863007864SAFE-T-SHIELD MouthpieceMNMP5002017-06-09
00850022357114Xenon Master Administration SetMN60012020-11-09
00850022357121Xenon Master Administration SetMN27002020-11-09
00850022357138Xenon Master Administration SetMN2891M2020-11-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10192253071405CARDINAL HEALTHCardinal Health 200, LLCBSJ2026-04-06
10192253071412CARDINAL HEALTHCardinal Health 200, LLCBSJ2026-03-23
10192253071429CARDINAL HEALTHCardinal Health 200, LLCBSJ2026-03-23
10192253071436CARDINAL HEALTHCardinal Health 200, LLCBSJ2026-03-23
10192253071443CARDINAL HEALTHCardinal Health 200, LLCBSJ2026-03-23
10192253071450CARDINAL HEALTHCardinal Health 200, LLCBSJ2026-03-23
10192253071467CARDINAL HEALTHCardinal Health 200, LLCBSJ2026-03-23
10197344137435MEDLINEMEDLINE INDUSTRIES, INC.BSJ2025-03-05
10197344131662MEDLINEMEDLINE INDUSTRIES, INC.BSJ2025-01-31
10197344131693MEDLINEMEDLINE INDUSTRIES, INC.BSJ2025-01-31
10197344131723MEDLINEMEDLINE INDUSTRIES, INC.BSJ2025-01-31
10612479274218McKessonMCKESSON MEDICAL-SURGICAL INC.BSJ2025-01-31
10612479274232McKessonMCKESSON MEDICAL-SURGICAL INC.BSJ2025-01-31
10612479274256McKessonMCKESSON MEDICAL-SURGICAL INC.BSJ2025-01-31
10612479274270McKessonMCKESSON MEDICAL-SURGICAL INC.BSJ2025-01-31
10612479274294McKessonMCKESSON MEDICAL-SURGICAL INC.BSJ2025-01-31
10197344131679MEDLINEMEDLINE INDUSTRIES, INC.BSJ2025-01-23
10197344131686MEDLINEMEDLINE INDUSTRIES, INC.BSJ2025-01-23
10197344131709MEDLINEMEDLINE INDUSTRIES, INC.BSJ2025-01-23
10197344131716MEDLINEMEDLINE INDUSTRIES, INC.BSJ2025-01-23
10197344103706MEDLINEMEDLINE INDUSTRIES, INC.BSJ2024-06-10
10193489135367MedlineMEDLINE INDUSTRIES, INC.BSJ2024-04-24
10193489135374MedlineMEDLINE INDUSTRIES, INC.BSJ2024-04-24
10193489135381MedlineMEDLINE INDUSTRIES, INC.BSJ2024-04-24
10197344097180MedlineMEDLINE INDUSTRIES, INC.BSJ2024-04-23
10197344097197MedlineMEDLINE INDUSTRIES, INC.BSJ2024-04-23
10197344097203MedlineMEDLINE INDUSTRIES, INC.BSJ2024-04-23
10197344097210MedlineMEDLINE INDUSTRIES, INC.BSJ2024-04-23
10197344097227MedlineMEDLINE INDUSTRIES, INC.BSJ2024-04-23
10197344097234MedlineMEDLINE INDUSTRIES, INC.BSJ2024-04-23