AccessGUDID - DEVICE: SmartPractice (00854498007351)

GUDID

Device Identifier (DI) Information

Brand Name: SmartPractice
Version or Model: AL7014PP
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AL7014PP
Company Name: Smarthealth, Inc.

Primary DI Number: 00854498007351
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 200
Labeler D-U-N-S® Number*: 061081477 *Terms of Use

Device Description: Finn Chambers on Scanpor 12mm PP, 200x1, 200/box

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):	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?
58299	Allergy testing adhesive strip, epicutaneous	A band of adhesive material designed to be used for epicutaneous allergy testing. The device typically consists of a central portion containing a series of transparent discs onto which are applied potentially allergenic substances; it includes on one side a hypoallergenic pressure-sensitive adhesive for application to the skin of the patient. The device may include additional strips that can be used for labelling, to aid diagnosis of skin reactions. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KXF	Applicator, Absorbent Tipped, Non-Sterile

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K013820	000

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
Special Storage Condition, Specify: Keep away from sunlight. Keep dry.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 672a62fa-cf4c-450a-9ac4-5e4893b30fe4
Public Version Date: April 22, 2025
Public Version Number: 4
DI Record Publish Date: December 02, 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
No Package DIs found

Secondary DI

[?]

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

Unit of Use DI

[?]

Unit of Use DI Number: 10854498007358 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: 1-800-878-3837
Email: info@smartpractice.com

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