AccessGUDID - DEVICE: Kernel (06928798600025)

GUDID

Device Identifier (DI) Information

Brand Name: Kernel
Version or Model: KN-4003B
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Xuzhou Kernel Medical Equipment Co., Ltd.

Primary DI Number: 06928798600025
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 530873660 *Terms of Use

Device Description: No description.

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?
34669	Ultraviolet phototherapy unit, home-use	A mains electricity (AC-powered), portable, device that includes a lamp which emits light in the ultraviolet (UV) band intended to treat dermatological disorders (e.g., psoriasis, dermatitis) in the home.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FTC	Light, Ultraviolet, Dermatological

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K132643	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: 09be4e64-4769-492b-aabc-cfaac7c53f45
Public Version Date: November 08, 2021
Public Version Number: 7
DI Record Publish Date: July 12, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status
36928798600026	12	06928798600025	In Commercial Distribution
26928798600029	10	06928798600025	In Commercial Distribution
16928798600022	8	06928798600025	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: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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