AccessGUDID - DEVICE: Halyard (10680651924114)

GUDID

Device Identifier (DI) Information

Brand Name: Halyard
Version or Model: 92411
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 18913
Company Name: Avanos Medical, Inc.

Primary DI Number: 10680651924114
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079375431 *Terms of Use

Device Description: No description.

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:	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?
47107	External pledget	A miniature, flat, sterile compress designed for external use. It is typically very small (e.g., a square or rectangular piece of less than 1.25 cm/0.5 inch sides) and made of cotton, gauze, or felt. It is used for topical application of medications, for mechanical protection, or to absorb discharged matter from wounds, and/or to improve dressing retention. Dedicated devices are available to apply drugs on the skin (e.g., erythromycin for acne treatment) and on the eyes (e.g., to deliver mydriatics). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FMF	Syringe, piston

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K941562	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 3e07f50d-135e-4126-abf1-6f68f7711b84
Public Version Date: November 16, 2018
Public Version Number: 4
DI Record Publish Date: January 31, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
30680651924118	25	10680651924114		In Commercial Distribution	CS

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(844)425-9273
Email: xxx@xxx.xxx

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

FDA TOOLS & RESOURCES