AccessGUDID - DEVICE: Suction jar 2L (ENOU4052USA9)

GUDID

Device Identifier (DI) Information

Brand Name: Suction jar 2L
Version or Model: 4052usa
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Nouvag AG

Primary DI Number: ENOU4052USA9
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 480610476 *Terms of Use

Device Description: scaled suction jar 2L with lid, sterilizable

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?
42446	Suction/irrigation system canister/bottle holder, single-use	A device intended to be used to hold a dedicated fluid or collection/specimen canister or bottle that is used within a suction and/or irrigation system. This device can be used to mount the canister/bottle(s) to the parent system when it is mobile (on wheels), or to mount the canister/bottle to a medical device service rail system or a wall rail (typically used on the ward). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BTA	Pump, Portable, Aspiration (Manual Or Powered)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K042943	000

Device Exempt from Premarket Submission: No 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: 8f50becf-770a-4ee8-8bd7-6a6ecaf7fa3f
Public Version Date: March 22, 2022
Public Version Number: 2
DI Record Publish Date: December 14, 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
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: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +41718466600
Email: info@nouvag.com

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