AccessGUDID - DEVICE: 3M™ ESPE™ (30348878600016)

GUDID

Device Identifier (DI) Information

Brand Name: 3M™ ESPE™
Version or Model: 12136
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 12136
Company Name: 3M COMPANY

Primary DI Number: 30348878600016
Issuing Agency: GS1
Commercial Distribution End Date: January 16, 2023
Device Count: 9
Labeler D-U-N-S® Number*: 830016148 *Terms of Use

Device Description: 3M™ ESPE™ Xerostomia Relief Spray, Sample Pack, 9 Canisters, 12136

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:	No
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?
47276	Oropharyngeal mucosa protection material	A substance intended to be applied to the mouth and/or pharynx to barrier/protect the mucosa from harmful influences (e.g., environmental, infectious), to treat minor pain and irritation, and/or to relieve mucosal dryness (xerostomia). It is comprised of various compounds [e.g., plant extracts, fat-soluble vitamins, hyaluronic acid (HA), glycerol/xylitol, mineral salts, viscosity enhancers, enzymes, and/or syrups]; it does not include a pharmaceutical agent. It is available in various forms (e.g., gel, toothpaste, fluid, tablet, lozenge, spray) typically for use in the home. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LFD	SALIVA, ARTIFICIAL

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No 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: b5ad6f31-4643-4d18-998f-e43a09b3e0e8
Public Version Date: January 17, 2023
Public Version Number: 3
DI Record Publish Date: October 31, 2018

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
50348878600010	12	30348878600016	2023-01-16	Not in Commercial Distribution	CASE

Secondary DI

[?]

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

Unit of Use DI

[?]

Unit of Use DI Number: 00348878600015 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)634-2249
Email: 3Mhealthcarecompliance@mmm.com

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