FDA UDI
In Commercial Distribution
🇺🇸 United States
d-Nav®
DI: 00860001044201
·
Model: V1m00b054i
·
HYGIEIA, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- d-Nav®
- Primary DI
- 00860001044201
- Version / Model
- V1m00b054i
- Company Name
- HYGIEIA, INC.
- Labeler DUNS
- 073601434
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-04-05
- Public Version
- 1
- Public Version Date
- 2019-04-15
- Public Version Status
- New
- Public Device Record Key
- 48d0b689-0512-4324-b1bf-ad91f248f156
Device Description
Hygieia d-Nav System Phone App - Apple iOS Operating System
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NDC | Calculator, Drug Dose | Anesthesiology | 868.1890 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860001044201 | GS1 |
Customer Contacts
- Phone
- 8888214497
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K181916 | 000 |