FDA.reportPublic FDA data

AngiAssist®

Primary DI
00850033705034
Brand
AngiAssist®
Company
Angioadvancements, LLC
Model
AA0608-01 and AA0608
Catalog number
AA0608-01 and AA0608
Published
2022-07-20
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
BYXTubing, Pressure And Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYXTubing, Pressure And AccessoriesAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850033705034PrimaryGS10
00850033705027Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850033705034008500337050348500337050340850033705034
00850033705027008500337050278500337050270850033705027

GMDN Terms#

Term, Definition table
TermDefinition
Gas-sampling/monitoring respiratory tubing, single-useA length of flexible noninvasive tube(s) primarily intended to be connected between a tube/mask breathing circuit connector and a respiratory gas measuring instrument [e.g., a carbon dioxide (CO2) or multi-gas analyser, manometer/pressure monitor] for gas pressure or flow monitoring and/or gas sampling; a microbial filter may be included. It is not intended for delivery of medical gas to the patient and does not include a patient mask or nasal cannula. This is a single-use device.

Regulatory Flags#

DUNS number
965605210
Device count
40
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850033705072Co2mmander® ELITECOM915COM9152022-08-12
00850033705003Co2mmander® ELITECOM915-01 or COM915 COM915-01 2022-07-20
00850033705089AngiAssist®AA0608AA06082022-08-12
00850033705096AngiAssist®AA0608AA06082022-08-12
00850033705058Medco2go Carbon Dioxide CartridgeCO2/31813CO2/318132022-08-09
00850033705027AngiAssist®AA0608-01 and AA0608 AA0608-01 and AA0608 2022-07-20

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10197344162710MEDLINEMEDLINE INDUSTRIES, INC.BYX2025-12-12
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