Identity
- Trade Name
- Dover FDA UDI
- Generic Name
- Gravity enema set FDA UDI
- Device Name
- Flatus Bag with Rectal Tube, Non-Lubricated Tip 24 Fr/Ch (8.0 mm) x 19 in. (48.3 cm). FDA UDI
- Model / Reference
- 145524 FDA UDI
- Description
- Flatus Bag with Rectal Tube, Non-Lubricated Tip 24 Fr/Ch (8.0 mm) x 19 in. (48.3 cm). FDA UDI
Identifiers
- Catalog Number
- 145524 FDA UDI
- Primary DI / UDI-DI
- 10192253028997 FDA UDI
- FDA Product Code
- FCE FDA UDI
- GMDN Term
- Gravity enema set FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 876.5210 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
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 19 Inch FDA UDICatheter Gauge — 24 French FDA UDI
Category: Gravity enema set
Dover by Cardinal Health 200, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Gravity enema set.
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- Dover — Cardinalhealth · Class I
- Dover — Cardinalhealth · 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
- Cardinal Health 200, LLC
Sources (1)
- FDA UDI 9db274c7-d54d-4193-a500-8386686491d2 36 fields · synced Jun 8, 2026