AccessGUDID - DEVICE: LMA AIRWAY MANAGEMENT (25060112314739)

GUDID

Device Identifier (DI) Information

Brand Name: LMA AIRWAY MANAGEMENT
Version or Model: IPN915395
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 130099
Company Name: TELEFLEX INCORPORATED

Primary DI Number: 25060112314739
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 002348191 *Terms of Use

Device Description: LMA Fastrach™ Stabiliser Rod

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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?
60376	Endotracheal tube stabilization rod	A non-sterile device intended to be used to facilitate exchange of an in situ laryngeal airway for an endotracheal tube (ETT) by stabilizing the position of the inserted ETT as the laryngeal airway is withdrawn. It typically consists of a semi-flexible rod which functions as an extension of the ETT during the exchange. This is a reusable device intended to be sterilized prior to use.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CAE	AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY

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 [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Dark cool environment avoid direct sunlight

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 1c2ec8fb-c68b-4f8a-b9e4-93f47ba39b45
Public Version Date: August 19, 2021
Public Version Number: 1
DI Record Publish Date: August 11, 2021

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
45060112314733	10	35060112314736		In Commercial Distribution	Carton
35060112314736	10	25060112314739		In Commercial Distribution	Bag

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: Yes
DM DI Number: 15060112314732
CLOSE

Production Identifier(s) in UDI

[?]

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

Customer Contact

[?]

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

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