FDA UDI
In Commercial Distribution
🇺🇸 United States
NFLOW INFANT BONNET, DARK GREY, SIZE 1
DI: 05030267088454
·
Model: 4707001
·
Intersurgical Incorporated
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- NFLOW INFANT BONNET, DARK GREY, SIZE 1
- Primary DI
- 05030267088454
- Version / Model
- 4707001
- Company Name
- Intersurgical Incorporated
- Labeler DUNS
- 785952607
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-10-25
- Public Version
- 2
- Public Version Date
- 2022-02-07
- Public Version Status
- Update
- Public Device Record Key
- 7bbbada2-d689-4c2d-852a-c2cf66777664
Device Description
NFLOW INFANT BONNET, DARK GREY, SIZE 1
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- Yes
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JAY | Support, Breathing Tube | Anesthesiology | 868.5280 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 17142 | Infant head cap | A small covering designed as a cap intended to be worn by a patient in infancy (an infant). It is primarily used to prevent loss of heat from the head and is typically made of fabric materials, e.g., cotton. This is a reusable garment. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 05030267093366 | GS1 | 20 | In Commercial Distribution | ||
| Primary | 05030267088454 | GS1 |
Customer Contacts
- Phone
- 3154512900
- [email protected]