AccessGUDID - DEVICE: Gravity Drainage Bag (H862TC6000)

GUDID

Device Identifier (DI) Information

Brand Name: Gravity Drainage Bag
Version or Model: TC600
Commercial Distribution Status: In Commercial Distribution
Catalog Number: TC600
Company Name: URESIL, LLC

Primary DI Number: H862TC6000
Issuing Agency: HIBCC
Commercial Distribution End Date: October 31, 2026
Device Count: 1
Labeler D-U-N-S® Number*: 192559557 *Terms of Use

Device Description: Optimus 600 Gravity Drainage Bag w/20" I.T.

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):	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?
11301	Closed-wound/centesis drainage receptacle	A sterile container designed to be connected to an invasive drain/drainage catheter (not included) to collect fluids or purulent material being removed during drainage of a body cavity, a closed-wound, and/or the bile duct; it is not intended for drainage of cerebrospinal fluid (CSF) or blood. It is typically in the form of a bottle, bag, or bulb with fluid volume markers, and might include a hand-operated pump (e.g., suction bulb) and tubing; it does not include any invasive components or powered devices. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EXF	Bag, Bile Collecting

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: Yes
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
Total Volume: 600 Milliliter
Length: 20 Centimeter

Device Record Status

Public Device Record Key: 7267cbee-77c4-4c87-a492-9065fd6df542
Public Version Date: April 15, 2022
Public Version Number: 5
DI Record Publish Date: September 11, 2017

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
H862TC6002	2	H862TC6001	2026-10-31	In Commercial Distribution	SHIPPER
H862TC6001	10	H862TC6000	2026-10-31	Not in Commercial Distribution	DISPENSER

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

Customer Contact

[?]

Phone: 1-800-538-7374
Email: SALES@URESIL.COM

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