AccessGUDID - DEVICE: Penlon (05051977000260)

GUDID

Device Identifier (DI) Information

Brand Name: Penlon
Version or Model: 53454
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 53454
Company Name: PENLON LTD

Primary DI Number: 05051977000260
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 458942687 *Terms of Use

Device Description: KEY FILLER ASSEMBLY FOR SEVOFLURANE

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?
36980	Sevoflurane anaesthesia vaporizer	A device used to vaporize the anaesthetic agent sevoflurane and deliver a controlled amount of the agent to a patient being prepared for surgery. The device is usually mounted to an anaesthesia system or ventilator.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CAD	Vaporizer, Anesthesia, Non-Heated

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K053564	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0df05379-02b8-47d6-a0fd-e6d16d3d44a1
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 07, 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: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 800-328-6216
Email: customer.service@penlon.com

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