AccessGUDID - DEVICE: ERBE (04050147000322)

GUDID

Device Identifier (DI) Information

Brand Name: ERBE
Version or Model: 10340-000
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 10340-000
Company Name: Erbe Elektromedizin GmbH

Primary DI Number: 04050147000322
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 316116623 *Terms of Use

Device Description: ERBE ESM 2 suction module

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?
33579	Surgical irrigation/aspiration pump, reusable	An electrically-powered device, which may include noninvasive accessories, intended to both irrigate and aspirate (i.e., capable of both functions) body cavities and wounds typically during an endoscopic and/or orthopaedic surgical procedure, usually to facilitate observation. It is intended to remove tissues/fluids/debris through suction, and to irrigate the surgical site with a sterile fluid (e.g., saline); it is not intended to administer parenteral fluids or drugs. The device may include collection containers or tubing; it does not include patient contact devices (e.g., handpiece/tip, catheter). This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FQH	LAVAGE, JET

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K072404	000
K231023	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
Special Storage Condition, Specify: Keep away from heat and direct sunlight
Handling Environment Temperature: between -25 and 50 Degrees Celsius
Special Storage Condition, Specify: Keep dry
Storage Environment Temperature: between -25 and 50 Degrees Celsius
Handling Environment Humidity: between 15 and 80 Percent (%) Relative Humidity
Storage Environment Humidity: between 15 and 80 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6caa9a13-953f-489b-add5-9450188abc55
Public Version Date: February 09, 2024
Public Version Number: 4
DI Record Publish Date: September 20, 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: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +4970717550
Email: info@erbe-med.com

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES