AccessGUDID - DEVICE: Hollister (00610075097739)

GUDID

Device Identifier (DI) Information

Brand Name: Hollister
Version or Model: 9773
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: HOLLISTER INCORPORATED

Primary DI Number: 00610075097739
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 005527098 *Terms of Use

Device Description: Wound Drainage Collector with Barrier

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):	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?
62850	Wound drainage bag	A plastic pouch designed to be attached with an adhesive to the skin around a large wound or fistula and intended to be used as a receptacle for exudate, blood, or other bodily wastes. It is a one-piece device, supplied in a variety of sizes, with a large-area adhesive flange that can be cut to fit closely around a wound, and which may provide some skin protection. It may have a tubular outlet and be connected to a drain system; it does not include accessory devices (i.e., not a kit). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GDS	BAG, STOMAL

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
Outer Diameter: 7.6 Centimeter

Device Record Status

Public Device Record Key: f458a990-10fe-497a-a5b3-2cafa1e2e2ff
Public Version Date: September 29, 2022
Public Version Number: 1
DI Record Publish Date: September 21, 2022

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
20610075097733	12	00610075097739		In Commercial Distribution	CASE

Secondary DI

[?]

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

Unit of Use DI

[?]

Unit of Use DI Number: 00610075072613 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)323-4060
Email: cs@hollister.com

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