Identity
- Trade Name
- Neotech Bridge® FDA UDI
- Generic Name
- Breast pump support kit, reusable FDA UDI
- Device Name
- The Neotech Bridge is a breastfeeding assistance device intended to deliver supplemental nutrition to an infant latched at the breast/chest. FDA UDI
- Model / Reference
- Kit – Bridge with Extension and 20ML & 60ML Syringes FDA UDI
- Description
- The Neotech Bridge is a breastfeeding assistance device intended to deliver supplemental nutrition to an infant latched at the breast/chest. FDA UDI
Identifiers
- Catalog Number
- N8001-Kit FDA UDI
- Primary DI / UDI-DI
- 00812594013478 FDA UDI
- FDA Product Code
- HGY FDA UDI
- GMDN Term
- Breast pump support kit, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 884.5150 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
Yes
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Breast pump support kit, reusable
Neotech Bridge® by Neotech Products LLC — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Breast pump support kit, reusable.
- Spectra — Uzinmedicare Co., Ltd. · Class II
- Maymom Double Flange Set for Medela Pump in Style Advanced Pump, 21 mm — MAYMOM LLC · Class II
- Spectra — Uzinmedicare Co., Ltd. · Class II
- Spectra — Uzinmedicare Co., Ltd. · Class II
- Unimom — Unimom.Co · Class II
- PNSMX Resupply kits — Medela LLC · Class II
- Hands-free Breast shields, 24mm — Medela LLC · Class II
- Spectra — Uzinmedicare Co., Ltd. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Neotech Products LLC
Sources (2)
- FDA UDI d54b330b-45ee-4787-b55a-7062cb72ab01 34 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 4, 2026