AccessGUDID - DEVICE: Bausch + Lomb (00757770529285)

GUDID

Device Identifier (DI) Information

Brand Name: Bausch + Lomb
Version or Model: N8182 A
Commercial Distribution Status: In Commercial Distribution
Catalog Number: N8182 A
Company Name: Bausch & Lomb Incorporated

Primary DI Number: 00757770529285
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 196603781 *Terms of Use

Device Description: LARYNGECTOMY TUBE NYLON SIZE-8

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:	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?
62136	Laryngectomy tube, non-sterile	A non-sterile hollow device intended to maintain tracheostoma patency after laryngectomy to provide an airway for the patient and to prevent tracheostomal stenosis in the months following the procedure. It is a soft plastic or silicone curved tube, similar to a tracheostomy tube, contoured to fit the postoperative tracheal anatomy, and may have an inner cannula and be fenestrated to allow simultaneous use with a tracheoesophageal speech valve. It is held in place with a strap or band around the neck and is typically regularly removed and reinserted by the patient. This is a reusable device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
KAC	Tube, Laryngectomy

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 32681f37-81a4-4dd7-bed2-b007bf22e4b4
Public Version Date: May 10, 2024
Public Version Number: 3
DI Record Publish Date: September 24, 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
No Package DIs found

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: No
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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