FDA.reportPublic FDA data

ANEclear

Primary DI
00863034000329
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
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BYWDevice, Rebreathing
CBNApparatus, Gas-Scavenging

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYWDevice, RebreathingAnesthesiology1
CBNApparatus, Gas-ScavengingAnesthesiology2

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).

Contacts#

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

Regulatory Flags#

DUNS number
824640226
Device count
1
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10863034000326ANEclear2900202018-02-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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24250105630521Paediatric Mask; NewbornVBM Medizintechnik GmbHBYW2025-04-25
24250105630538Paediatric Mask; InfantVBM Medizintechnik GmbHBYW2025-04-25
24250105630545Paediatric Mask; ChildVBM Medizintechnik GmbHBYW2025-04-25
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24026704916652HUDSON RCITELEFLEX INCORPORATEDCBN2024-01-23
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