AccessGUDID - DEVICE: Acu-Life (HE) (00079573105849)

GUDID

Device Identifier (DI) Information

Brand Name: Acu-Life (HE)
Version or Model: 400584
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: APOTHECARY PRODUCTS, LLC

Primary DI Number: 00079573105849
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 18
Labeler D-U-N-S® Number*: 092312735 *Terms of Use

Device Description: EAR PLUGS FOAM 18PR 6/72

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):	Yes
Device labeled as "Not made with natural rubber latex":	No
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?
35024	Earplugs, single-use	A device, usually used as a pair, made of rubber or pliable plastic/silicone material intended to be inserted into the outer ear canal for protection against excessive noise levels or water entering the ears when swimming/bathing. This device may be premoulded (preformed) or mouldable. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EWD	Protector, Hearing (Insert)

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
No Device Sizes

Device Record Status

Public Device Record Key: 57d25802-c17e-4881-ba43-16c006a2751c
Public Version Date: June 10, 2022
Public Version Number: 2
DI Record Publish Date: September 10, 2020

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
10079573105846	6	00079573105849		In Commercial Distribution	BAG
20079573105843	12	10079573105846		In Commercial Distribution	case

Secondary DI

[?]

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

Unit of Use DI

[?]

Unit of Use DI Number: 40079573105847 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: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 952-890-1940
Email: UDI@APOTHECARYPRODUCTS.COM

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