FDA.reportPublic FDA data

AngiAssist®

Primary DI
00850033705096
Brand
AngiAssist®
Company
Angioadvancements, LLC
Model
AA0608
Catalog number
AA0608
Device description
AngiAssist® Case of 1 x 10.
Published
2022-08-12
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
false

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
00850033705096PackageGS110In Commercial Distribution
00850033705089PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850033705096008500337050968500337050960850033705096
00850033705089008500337050898500337050890850033705089

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
965605210
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
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
false
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
00850033705058Medco2go Carbon Dioxide CartridgeCO2/31813CO2/318132022-08-09
00850033705034AngiAssist®AA0608-01 and AA0608 AA0608-01 and AA0608 2022-07-20
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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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
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