AccessGUDID - DEVICE: CHS (50628725096679)

GUDID

Device Identifier (DI) Information

Brand Name: CHS
Version or Model: SB1005-M
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SB1005-M
Company Name: Canadian Hospital Specialties Limited

Primary DI Number: 50628725096679
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 240992693 *Terms of Use

Device Description: SITZ BATH MAUVE WITH TUBING

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":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	No
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?
33676	Sitz bath, non-powered	A tub that is filled with heated water and intended for use in external hydrotherapy to relieve pain or pruritus and to accelerate the healing of inflamed or traumatized tissues of the perianal and perineal areas. The patient immerses only the hips and buttocks, keeping the legs outside of the tub. It is typically used to maintain patient hygiene and to alleviate pain and discomfort caused by haemorrhoids, uterine cramps, labour, and/or other diseases of the pelvic, abdominal and perineal area (e.g., prostate, bladder, bowel, vaginal disorders).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KTC	Bath, Sitz, Nonpowered

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: 2c167225-915b-4f5f-bd20-3a3557071cfd
Public Version Date: September 13, 2023
Public Version Number: 3
DI Record Publish Date: July 06, 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: 00628725096674 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: 9058259300
Email: regulatory.affairs@chsltd.com

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES