AccessGUDID - DEVICE: d-Nav® (00860001044201)

GUDID

Device Identifier (DI) Information

Brand Name: d-Nav®
Version or Model: V1m00b054i
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: HYGIEIA, INC.

Primary DI Number: 00860001044201
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 073601434 *Terms of Use

Device Description: Hygieia d-Nav System Phone App - Apple iOS Operating System

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?
36727	Calculator, programmable	A small electronic calculator that can be programmed to carry out calculations related to a specific medical treatment, e.g., measuring infusion dosages, or the degree of stenosis in a coronary vessel where measurements are taken from x-ray films using an electronic calliper coupled to a programmed calculator. Dedicated software may be necessary to effect the device's intended purpose.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
NDC	Calculator, Drug Dose

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K181916	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 48d0b689-0512-4324-b1bf-ad91f248f156
Public Version Date: April 15, 2019
Public Version Number: 1
DI Record Publish Date: April 05, 2019

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: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 8888214497
Email: xx@xx.xx

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