ANEclear

Primary DI
10863034000326
Brand
ANEclear
Company
ANECARE, LLC
Model
2
Catalog number
90020
Device description
Anesthesia Recovery Device
Published
2018-02-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BYWDevice, Rebreathing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYWDevice, RebreathingAnesthesiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K033028000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K033028000ANEFIN, MODEL 100Axon Medical2005-07-22CBN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10863034000326PackageGS120In Commercial Distribution
00863034000329PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086303400032610863034000326
00863034000329008630340003298630340003290863034000329

GMDN Terms#

Term, Definition table
TermDefinition
Anaesthesia workstation gas scavengerA pneumatically-powered device that is a component of an anaesthesia workstation and connects between the expiratory valve or port of a breathing circuit and the extraction system enabling the waste anaesthetic, exhaled, or other trace gasses to be removed under controlled conditions from the work environment and channelled to the outside of the building. Filters or absorbers may be required to clean the removed gasses before discharging to the atmosphere. This device is also known as an anaesthetic gas scavenging system (AGSS).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
801-977-8877sslatter@anecare.com

Regulatory Flags#

DUNS number
824640226
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
false
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
00863034000329ANEclear2900202018-02-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
14250105630524Paediatric Mask; NewbornVBM Medizintechnik GmbHBYW2025-04-25
14250105630531Paediatric Mask; InfantVBM Medizintechnik GmbHBYW2025-04-25
14250105630548Paediatric Mask; ChildVBM Medizintechnik GmbHBYW2025-04-25
24250105630521Paediatric Mask; NewbornVBM Medizintechnik GmbHBYW2025-04-25
24250105630538Paediatric Mask; InfantVBM Medizintechnik GmbHBYW2025-04-25
24250105630545Paediatric Mask; ChildVBM Medizintechnik GmbHBYW2025-04-25
06975029700054MTEHFYAFBeijing Xingjian Yongzhen Technology Co. , Ltd.BYW2024-06-12
06975029700061MTEHFYAFBeijing Xingjian Yongzhen Technology Co. , Ltd.BYW2024-06-12
06975029700078MTEHFYAFBeijing Xingjian Yongzhen Technology Co. , Ltd.BYW2024-06-12
00840155400009MedSource Rebreather MaskMEDSOURCE INTERNATIONAL LLCBYW2021-05-27
00840155400047MedSource Rebreather MaskMEDSOURCE INTERNATIONAL LLCBYW2021-05-27
00840155400016MedSource Rebreather MaskMEDSOURCE INTERNATIONAL LLCBYW2021-05-27
00840155400054MedSource Rebreather MaskMEDSOURCE INTERNATIONAL LLCBYW2021-05-27
14250105628507n.a.VBM Medizintechnik GmbHBYW2020-08-25
14250105628514n.a.VBM Medizintechnik GmbHBYW2020-08-25
14250105628521n.a.VBM Medizintechnik GmbHBYW2020-08-25
24250105628504n.a.VBM Medizintechnik GmbHBYW2020-08-25
24250105628511n.a.VBM Medizintechnik GmbHBYW2020-08-25
24250105628528n.a.VBM Medizintechnik GmbHBYW2020-08-25
00604351600515Monaghan Medical CorporationMonaghan Medical CorporationBYW2020-07-30
50604351600510Monaghan Medical CorporationMONAGHAN MEDICAL CORPORATIONBYW2020-07-30
00863034000329ANEclearANECARE, LLCBYW2018-02-27
00604351600508AE II BANMonaghan Medical CorporationBYW2017-07-25
50604351600503AE II BANMONAGHAN MEDICAL CORPORATIONBYW2017-07-25