FDA.report

Tubing, Smooth Interior, Disposable, 1.375"-36"

Primary DI
00817081024692
Brand
Tubing, Smooth Interior, Disposable, 1.375"-36"
Company
A-M SYSTEMS, LLC
Model
Tubing, Smooth Interior, Disposable, 1.375"-36" -
Catalog number
243400
Device description
Tubing, Smooth Interior, Disposable, 1.375"-36"
Published
2020-01-15
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

Related Records

Product Codes

CodeName
BYXTubing, Pressure And Accessories

Product Code Classifications

CodeDeviceSpecialtyClass
BYXTubing, Pressure And AccessoriesAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00817081024692PackageGS11In Commercial Distribution
00817081024685PrimaryGS10

GMDN Terms

TermDefinition
High-pressure medical gas tubingA flexible, cylindrical device that is used to deliver and withstand gases under very high pressure, i.e., greater than 200 bar/3000 pounds per square inch (psi). It may be composed of any of several malleable or semi-rigid materials, e.g., plastic, rubber or nylon, and braided with cotton wool and/or stainless steel. It is typically used to transport high pressure compressed medical gas to a pressure regulating device. It is available in various lengths, including standard coil lengths. This is a reusable device.

Sterilization Methods

Method

Contacts

PhoneEmail
3606838300sales@a-msystems.com

Regulatory Flags

DUNS number
020275145
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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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