FDA.report

RUSCH

Primary DI
34026704624196
Brand
RUSCH
Company
TELEFLEX INCORPORATED
Model
IPN049455
Catalog number
395552
Device description
Oxygen Barb Size 3/4" O.D.
Published
2019-05-09
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
BZACONNECTOR, AIRWAY (EXTENSION)

Product Code Classifications

CodeDeviceSpecialtyClass
BZAConnector, Airway (Extension)Anesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
34026704624196PrimaryGS10
14026704624192Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
3402670462419634026704624196
1402670462419214026704624192

GMDN Terms

TermDefinition
Oxygen administration kit, sterileA collection of sterile devices designed for oxygen (O2) delivery that may include a mask, a nasal cannula, oxygen tubing, and connectors. This is a single-use device.

Sterilization Methods

Method

Contacts

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

Regulatory Flags

DUNS number
002348191
Device count
50
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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