FDA.report

HUDSON RCI

Primary DI
24026704580310
Brand
HUDSON RCI
Company
TELEFLEX INCORPORATED
Model
IPN042448
Catalog number
1410
Device description
SMOOTH-FLO® CORR-A-TUBE® II Corrugated Tubing 15 cm (6 in.) Length
Published
2018-09-15
Public version status
Update
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
BZOSET, TUBING AND SUPPORT, VENTILATOR (W HARNESS)

Product Code Classifications

CodeDeviceSpecialtyClass
BZOSet, Tubing And Support, Ventilator (W Harness)Anesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
24026704580310PackageGS15Not in Commercial Distribution
04026704580316PrimaryGS10
34026704580317Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
2402670458031024026704580310
04026704580316040267045803164026704580316
3402670458031734026704580317

GMDN Terms

TermDefinition
Aerosol delivery tubingA non-sterile length of a flexible, hollow tube, typically large bore (e.g., 22 mm), used in conjunction with an oxygen mask, endotracheal (ET) tube, humidifier, or nebulizer for the delivery of aerosolized humidification, typically oxygen enriched. It is typically supplied in standard coil lengths and is cut by clinical staff to usable lengths. This is a single-use device.

Sterilization Methods

Method

Contacts

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

Regulatory Flags

DUNS number
002348191
Device count
10
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

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