FDA UDI
In Commercial Distribution
🇺🇸 United States
Neotech ChinStrap™
DI: 10812594012850
·
Model: Macro
·
Neotech Products LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
20
Basic Information
- Brand Name
- Neotech ChinStrap™
- Primary DI
- 10812594012850
- Version / Model
- Macro
- Catalog Number
- N789
- Company Name
- Neotech Products LLC
- Labeler DUNS
- 198013435
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 20
- Record Status
- Published
- Publish Date
- 2021-06-14
- Public Version
- 4
- Public Version Date
- 2023-09-19
- Public Version Status
- Update
- Public Device Record Key
- c1f23cf3-0b5f-4190-9f66-f995787c0e4b
Device Description
The Neotech ChinStrap is intended to help keep a patient’s mouth closed during respiratory therapy. It is intended for use on pediatric (neonates, infants and children) patients.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- 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
- Yes
- 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 |
|---|---|---|---|---|
| CCX | Support, Patient Position | Anesthesiology | 868.6820 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 10284 | Pressure bandage, non-latex, single-use | A strip or roll of fabric or plastic material (non-natural rubber latex) intended to be applied to and compress a local area of the body for one or more preventative/therapeutic applications (e.g., prevent oedema, support injuries associated with minor trauma, treat disorders of venous return). It may be described as a sports tape intended for support while allowing movement, or described as a compression bandage; it is not intended to be used in association with open wounds. It is intended for use in the home or healthcare facility. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00812594012853 | GS1 | ||||
| Primary | 10812594012850 | GS1 |