FDA UDI
In Commercial Distribution
🇺🇸 United States
Neotech Bridge®
DI: 00812594013478
·
Model: Kit – Bridge with Extension and 20ML & 60ML Syringes
·
Neotech Products LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Neotech Bridge®
- Primary DI
- 00812594013478
- Version / Model
- Kit – Bridge with Extension and 20ML & 60ML Syringes
- Catalog Number
- N8001-Kit
- Company Name
- Neotech Products LLC
- Labeler DUNS
- 198013435
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-06-06
- Public Version
- 2
- Public Version Date
- 2023-09-21
- Public Version Status
- Update
- Public Device Record Key
- d54b330b-45ee-4787-b55a-7062cb72ab01
Device Description
The Neotech Bridge is a breastfeeding assistance device intended to deliver supplemental nutrition to an infant latched at the breast/chest.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- Yes
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- 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 |
|---|---|---|---|---|
| HGY | Pump, Breast, Non-Powered | Obstetrics/Gynecology | 884.5150 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61734 | Breast pump support kit, reusable | A collection of items intended to be used in conjunction with a manual or electric breast pump (not included) to assist mothers in extracting milk from the breast for collection and/or feeding an infant. It typically includes various items such as funnel-like breast shields, tubing, connectors, and infant feeding bottle. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00812594013478 | GS1 |