AccessGUDID - DEVICE: AutoSqueeze (00384706150017)

GUDID

Device Identifier (DI) Information

Brand Name: AutoSqueeze
Version or Model: OP 6150
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: OWEN MUMFORD USA INCORPORATED

Primary DI Number: 00384706150017
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 803401454 *Terms of Use

Device Description: Autosqueeze eyedrop aid device in a bag

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):	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?
61580	Eye dropper bottle aid	A non-sterile device intended to be attached to an eye dropper bottle to assist with the self-administration of an eye irrigation/treatment solution. It is typically a plastic device intended to assist with positioning of the nozzle, focusing of the eye, and/or squeezing of the bottle. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KCM	Dropper, Ent

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: 6f50c081-9845-4e13-9baa-0b2c39c30f17
Public Version Date: June 28, 2023
Public Version Number: 1
DI Record Publish Date: June 20, 2023

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

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: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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