AccessGUDID - DEVICE: Angel of Water (B149CM11)

GUDID

Device Identifier (DI) Information

Brand Name: Angel of Water
Version or Model: CM-1
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: LIFESTREAM PURIFICATION SYSTEM LLC

Primary DI Number: B149CM11
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 005549337 *Terms of Use

Device Description: Colon Irrigation Device

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?
43827	Colonic lavage system, gravity-flow	An assembly of devices designed for the irrigation, washing, and evacuation of debris from the colon. It typically consists of a fluid reservoir, tubing, nozzle, and controls that regulate the temperature and pressure of the gravity-induced water flow from a tap (faucet) and into the rectum. The device may include a console-type toilet and fittings to allow connection to water and sewer pipes for the effluent. The system provides colonic hydrotherapy to remove damaged tissue and/or debris (e.g., faeces, foreign objects) in emergency departments, and to clean/evacuate the colon for endoscopic/surgical procedures.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KPL	Colonic Irrigation System

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K003720	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: af4bd1a2-5e11-46f6-9b8a-e7a3af3e808c
Public Version Date: December 19, 2023
Public Version Number: 1
DI Record Publish Date: December 11, 2023

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: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 5127078383
Email: info@angelofwater.com

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