AccessGUDID - DEVICE: RUSCH (04026704002672)

GUDID

Device Identifier (DI) Information

Brand Name: RUSCH
Version or Model: IPN040900
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 102004-000070
Company Name: TELEFLEX INCORPORATED

Primary DI Number: 04026704002672
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 002348191 *Terms of Use

Device Description: Endotracheal tube for laser surgery

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	Yes
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
36064	Laser-resistant endotracheal tube	A hollow cylinder that is inserted into the trachea used to secure airway patency and/or for anaesthesia administration, and which is not damaged or easily set on fire if inadvertently irradiated by a laser beam during surgery around the head, throat, or neck. This device would typically be employed when laser surgery is being applied to the patient's head/neck area. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BTR	Tube, tracheal (w/wo connector)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K935842	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Keep away from sunlight; Keep dry

Clinically Relevant Size

[?]

Size Type Text
Lumen/Inner Diameter: 7 Millimeter
Device Size Text, specify: 7.0

Device Record Status

Public Device Record Key: e3444b69-92c9-4c04-b5ae-a89b525ab917
Public Version Date: June 03, 2019
Public Version Number: 3
DI Record Publish Date: October 16, 2015

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
24026704002676	2	04026704002672		In Commercial Distribution	Box
44026704002670	46	24026704002676		In Commercial Distribution	Carton

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(919)544-8000
Email: CS@TELEFLEX.COM

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