FDA.report

HUDSON RCI

Primary DI
24026704916645
Brand
HUDSON RCI
Company
TELEFLEX INCORPORATED
Model
IPN928017
Catalog number
8013
Device description
ISO-GARD CLEAR AIR MASK, WYE & CLAMPS
Published
2024-01-23
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

Contact Domains

Product Codes

CodeName
CBNAPPARATUS, GAS-SCAVENGING

Product Code Classifications

CodeDeviceSpecialtyClass
CBNApparatus, Gas-ScavengingAnesthesiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
24026704916645PackageGS120In Commercial Distribution
04026704582099PreviousGS10
14026704916648PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
2402670491664524026704916645
04026704582099040267045820994026704582099
1402670491664814026704916648

GMDN Terms

TermDefinition
Rebreathing oxygen face maskA non-sterile, flexible, form-shaped device designed to be placed over the nose and mouth to deliver a proportional mixture of air/oxygen (O2) to a patient's airway. It is made of non-conductive, soft, flexible polymers available in a range of sizes, and designed to create an airtight seal against the patient's face. The device may include tubing and various valves and connectors which may allow for connection to a central vacuum system to enable scavenging of residual (waste) anaesthetic gas from a patient in recovery; other respiratory equipment (e.g., nebulizer, humidifier, CPAP device) is not included. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(919)544-8000CS@TELEFLEX.COM

Regulatory Flags

DUNS number
002348191
Device count
1
DM exempt
false
Premarket exempt
false
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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