AccessGUDID - DEVICE: MEDLINE (00197344025445)

GUDID

Device Identifier (DI) Information

Brand Name: MEDLINE
Version or Model: RTMNK0082
Commercial Distribution Status: In Commercial Distribution
Catalog Number: RTMNK0082
Company Name: MEDLINE INDUSTRIES, INC.

Primary DI Number: 00197344025445
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 2
Labeler D-U-N-S® Number*: 025460908 *Terms of Use

Device Description: DRESSING,SHEET,HD,THERAHONEY,2X2, RETAIL

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:	Yes
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?
47773	Medical honey liquid barrier dressing	A material formed from medical grade honey intended to protect wounds or tissue surfaces by providing a non-occlusive external barrier to bacteria and the environment. It also helps to maintain a moist internal environment for wounds to assist the healing process. The material may be liquid or semi-liquid and is typically applied directly to the wound or tissue surface (e.g., ocular surface). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FRO	Dressing, wound, drug

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K120976	000

Device Exempt from Premarket Submission: No 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
Special Storage Condition, Specify: Protect from freezing, avoid excessive heat. Keep dry. Shield from direct sunlight.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 00e0f139-a4d3-43bc-af9b-af5b05055259
Public Version Date: October 21, 2024
Public Version Number: 1
DI Record Publish Date: October 11, 2024

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
20197344025371	4	30197344025378		In Commercial Distribution	ZI
30197344025378	6	00197344025445		In Commercial Distribution	CS

Secondary DI

[?]

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

Unit of Use DI

[?]

Unit of Use DI Number: 10197344025374 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)633-5463
Email: service@medline.com

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