Identity
- Trade Name
- CARDINAL HEALTH FDA UDI
- Generic Name
- Amniocentesis kit, medicated, single-use FDA UDI
- Device Name
- AMNIOCENTESIS PACK FDA UDI
- Model / Reference
- 29-0115C FDA UDI
- Description
- AMNIOCENTESIS PACK FDA UDI
Identifiers
- Catalog Number
- 29-0115C FDA UDI
- Primary DI / UDI-DI
- 10197106615195 FDA UDI
- FDA Product Code
- HIO FDA UDI
- GMDN Term
- Amniocentesis kit, medicated, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 884.1550 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
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: Amniocentesis kit, medicated, single-use
Cardinal Health by Cardinal Health 200, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Amniocentesis kit, medicated, single-use.
- Busse Hospital Disposables — ROBERT BUSSE & CO., INC. · Class I
- Curity — Cardinalhealth · Class I
- Medical Action Industries — MEDICAL ACTION INDUSTRIES INC. · Class I
- Aligned Medical Solutions — Aligned Medical Solutions · Class I
- Busse Hospital Disposables — ROBERT BUSSE & CO., INC. · Class I
- Sterling Medical Products — APOLLO MEDICAL PRODUCTS CORP.
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class II
- CARDINAL HEALTH — Cardinal Health 200, LLC · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Cardinal Health 200, LLC
Sources (1)
- FDA UDI bc33599d-61fd-47bd-97fb-7aeed9f00b13 35 fields · synced Jun 8, 2026