AccessGUDID - DEVICE: ERBE (04050147012974)

GUDID

Device Identifier (DI) Information

Brand Name: ERBE
Version or Model: 20325-233
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 20325-233
Company Name: Erbe Elektromedizin GmbH

Primary DI Number: 04050147012974
Issuing Agency: GS1
Commercial Distribution End Date: September 20, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 316116623 *Terms of Use

Device Description: Air and Water Tubing/Cap Set for Fujinon® Scopes

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?
60738	Endoscopic insufflation tubing set, single-use	A collection of flexible tubing intended to channel medical gas [e.g., carbon dioxide (CO2), medical air] from its source into a body cavity for insufflation during endoscopy (e.g., gastrointestinal endoscopy, laparoscopy, arthroscopy). It includes synthetic polymer tubing and associated connectors; it may in addition be intended for endoscopic lens drying, and may include additional tubing for delivery of a sterile irrigation solution for endoscopic irrigation. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FEQ	PUMP, AIR, NON-MANUAL, FOR ENDOSCOPE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K132340	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Keep dry
Special Storage Condition, Specify: Keep away from heat and direct sunlight

Clinically Relevant Size

[?]

Size Type Text
Length: 0.400 Meter

Device Record Status

Public Device Record Key: 11e229c3-9cfa-42fa-9e81-d4b3f8678ef7
Public Version Date: September 21, 2023
Public Version Number: 6
DI Record Publish Date: December 15, 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
04050147013537	10	04050147012974	2023-09-20	Not in Commercial Distribution	Level: 1
04050147013544	5	04050147013537	2023-09-20	Not in Commercial Distribution	Level: 2