AccessGUDID - DEVICE: LMA (05060112313226)

GUDID

Device Identifier (DI) Information

Brand Name: LMA
Version or Model: IPN046398
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MAD720
Company Name: TELEFLEX INCORPORATED

Primary DI Number: 05060112313226
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 002348191 *Terms of Use

Device Description: Pediatric Laryngo-Tracheal Mucosal Atomization Device without Syringe

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):	No
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?
31343	Laryngotracheal anaesthesia applicator	A non-sterile container (e.g., a spray bottle) that is prefilled with an anaesthetic agent and intended to be used to apply the agent to the oropharynx and upper airway, to relax laryngotracheal reflexes prior to an intervention [typically insertion of an endotracheal (ET) tube or other type of tracheal tube]. It is typically used on non-pharmacologically paralyzed patients where multiple reflexes (e.g., the gag reflex, glottic closure, vocal cord spasm, cough reflex, and bronchoconstriction) could make difficult or inhibit safe intervention. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CCT	APPLICATOR (LARYNGO-TRACHEAL), TOPICAL ANESTHESIA

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K153470	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 18dc33a9-2ab6-4b21-b3e1-4e94f79ae9fd
Public Version Date: October 17, 2019
Public Version Number: 4
DI Record Publish Date: September 16, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
25060112313220	4	15060112313223	2019-09-30	Not in Commercial Distribution	Case
15060112313223	25	05060112313226	2019-09-30	Not in Commercial Distribution	Box

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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