AccessGUDID - DEVICE: RUSCH (14026704612014)

GUDID

Device Identifier (DI) Information

Brand Name: RUSCH
Version or Model: IPN048428
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 145100
Company Name: TELEFLEX INCORPORATED

Primary DI Number: 14026704612014
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 002348191 *Terms of Use
Previous DI: 04026704545599

Device Description: RUSCH DOLPHIN WATER PROOF HANDLE: MINI

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
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?
46830	Laryngoscope handle, reusable	The hand-held segment of a laryngoscope (i.e., non-endoscopic rigid type) used to manipulate the laryngoscope blade during airway access and intubation. It is a cylindrical device that contains the batteries/light-emitting cells that provide energy/light for the airway-illuminating feature of the laryngoscope (e.g., small light bulb, fibreoptics), and can accommodate various blades. It is available in various sizes and may be magnetic resonance imaging (MRI) compatible. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CCW	LARYNGOSCOPE, RIGID

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

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

Sterilization Method [?]
High-level Disinfectant

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Store devices in accordance with the facility's hygiene practice policy in a containment system that ensures clean and dry storage.

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: MINI

Device Record Status

Public Device Record Key: 5e4ebd34-daea-4b39-80d6-5b5a0b96b4e2
Public Version Date: August 19, 2020
Public Version Number: 2
DI Record Publish Date: September 15, 2018