AccessGUDID - DEVICE: iCare Vacuum Cupping Set (00818318025352)

GUDID

Device Identifier (DI) Information

Brand Name: iCare Vacuum Cupping Set
Version or Model: CC200
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CC200
Company Name: Prime Holly Corporation

Primary DI Number: 00818318025352
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 12
Labeler D-U-N-S® Number*: 080445043 *Terms of Use

Device Description: iCare Vacuum Cupping Set

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):	No
Over the Counter (OTC):	Yes
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?
45164	Cupping therapy device	A dome typically made of glass or hard plastic intended to be used to manually produce sites of suction on the surface of the skin, or other soft tissues, in the practice of cupping therapy used by acupuncture and traditional Chinese medicine practitioners for localized healing or energy flow. The device is available in various sizes. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KNM	Device, Pressure Applying

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: 109f3917-a094-4816-a0f5-f41c782833f1
Public Version Date: May 26, 2025
Public Version Number: 1
DI Record Publish Date: May 16, 2025

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
10818318029081	50	00818318025352		In Commercial Distribution

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: 20818318029088 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: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 4085739889
Email: info@primeholly.com

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