AccessGUDID - DEVICE: Adapter set for bronchoscope (00843356100655)

GUDID

Device Identifier (DI) Information

Brand Name: Adapter set for bronchoscope
Version or Model: ASFB3
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: CYGNUS MEDICAL L.L.C.

Primary DI Number: 00843356100655
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 103169095 *Terms of Use

Device Description: Adapter set for bronchoscope, Single Use, 1 set, 120 sets per case.

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):	No
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?
65046	Endoscope dryer	An electrically-powered assembly of devices designed to dry the internal channel of an endoscope after washing, and to maintain dryness during storage, to prevent bacterial growth and endoscope deterioration. It consists of a user interface, a control unit, tubing/connectors for attaching to the endoscope, and may incorporate either an internal air pump or a connection for standard medical air supply; it may be designed for use on a bench or in a cabinet.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JRJ	Unit, Drying

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: 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: cc7edf27-b50d-4622-9f67-0a01d7811062
Public Version Date: February 20, 2023
Public Version Number: 3
DI Record Publish Date: July 13, 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
10843356100652	120	00843356100655		In Commercial Distribution

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

Customer Contact

[?]

No Customer Contact currently defined

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