Identity
- Trade Name
- O-Cal-ette FDA UDI
- Generic Name
- Nipple pad/ring, reusable FDA UDI
- Device Name
- Nursing Cup FDA UDI
- Model / Reference
- 9900 FDA UDI
- Description
- Nursing Cup FDA UDI
Identifiers
- Catalog Number
- 009900 FDA UDI
- Primary DI / UDI-DI
- 00308130099001 FDA UDI
- FDA Product Code
- HFS FDA UDI
- GMDN Term
- Nipple pad/ring, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.5630 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 3.38 Inch FDA UDI
Category: Nipple pad/ring, reusable
O-Cal-ette by Pharmics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Nipple pad/ring, reusable.
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- Silicone Nipple Shields (2pcs) — THINK GREEN LIMITED · Class I
- Breastfeeding Nipple Shield - Orthodontic Teat (Triangle Base) — THINK GREEN LIMITED · Class I
- Ultra-Thin Silicone Nipple Shields - L — THINK GREEN LIMITED · Class I
- Munchkin — MUNCHKIN INC. · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Pharmics, Inc.
Sources (1)
- FDA UDI e0175948-c0dc-45d7-af50-219bee1eecd4 36 fields · synced May 31, 2026