FDA.reportPublic FDA data

AngiAssist®

Primary DI
00850033705027
Brand
AngiAssist®
Company
Angioadvancements, LLC
Model
AA0608-01 and AA0608
Catalog number
AA0608-01 and AA0608
Published
2022-07-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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 tube(s) primarily intended to be used as an interface 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]. It may be intended for pressure and flow monitoring and/or gas sampling, but does not include any components intended for delivery of medical gas to the patient; a microbial filter may be included. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
965605210
Device count
40
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
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
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
00850033705034AngiAssist®AA0608-01 and AA0608 AA0608-01 and AA0608 2022-07-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20197344010261HUDSON RCIMEDLINE INDUSTRIES, INC.BYX2026-03-19
10197344011230HUDSON RCIMEDLINE INDUSTRIES, INC.BYX2026-02-13
10197344011155HUDSON RCIMEDLINE INDUSTRIES, INC.BYX2026-02-12
10197344042401HUDSON RCIMEDLINE INDUSTRIES, INC.BYX2026-02-12
10885632467431HalyardOWENS & MINOR DISTRIBUTION, INC.BYX2026-01-29
20197344010070HUDSON RCIMEDLINE INDUSTRIES, INC.BYX2026-01-12
10889483234402curaplex®SUNMED, LLCBYX2025-12-31
10889483225639AirLife™SUNMED, LLCBYX2025-12-18
10889483229279AirLife™SUNMED, LLCBYX2025-12-18
10197344162710MEDLINEMEDLINE INDUSTRIES, INC.BYX2025-12-12
10197344162727MEDLINEMEDLINE INDUSTRIES, INC.BYX2025-12-12
10197344011780HUDSON RCIMEDLINE INDUSTRIES, INC.BYX2025-12-03
10197344012237HUDSON RCIMEDLINE INDUSTRIES, INC.BYX2025-12-03
10197344012244HUDSON RCIMEDLINE INDUSTRIES, INC.BYX2025-12-03
10197344012572HUDSON RCIMEDLINE INDUSTRIES, INC.BYX2025-12-03
10197344042258HUDSON RCIMEDLINE INDUSTRIES, INC.BYX2025-12-03
20197344010063HUDSON RCIMEDLINE INDUSTRIES, INC.BYX2025-12-03
20197344011428HUDSON RCIMEDLINE INDUSTRIES, INC.BYX2025-11-24
10197344165315MEDLINEMEDLINE INDUSTRIES, INC.BYX2025-09-26
10197344165322MEDLINEMEDLINE INDUSTRIES, INC.BYX2025-09-26
14026704657060HUDSON RCITELEFLEX INCORPORATEDBYX2025-07-07
14026704656575HUDSON RCITELEFLEX INCORPORATEDBYX2025-07-03
10197344129942HUDSON RCIMEDLINE INDUSTRIES, INC.BYX2025-05-29
10197344009633HUDSON RCIMEDLINE INDUSTRIES, INC.BYX2025-05-09
10197344009640HUDSON RCIMEDLINE INDUSTRIES, INC.BYX2025-05-09
10197344009657HUDSON RCIMEDLINE INDUSTRIES, INC.BYX2025-05-09
10197344011216HUDSON RCIMEDLINE INDUSTRIES, INC.BYX2025-05-09
10197344011223HUDSON RCIMEDLINE INDUSTRIES, INC.BYX2025-05-09
10197344042234HUDSON RCIMEDLINE INDUSTRIES, INC.BYX2025-05-09
10889483603352Vital Signs™AirLife Finland OyBYX2025-04-22