Identity
- Trade Name
- Cleansing Enema Set FDA UDI
- Generic Name
- Manual enema device, single-use FDA UDI
- Device Name
- Cleansing Enema Set: 1500mL Enema Bag, 60" Inlet Tubing, Tubing Clamp, Protection Clamp, Protection Cap, Castile Soap Concentrate, 45x42cm Moisture Proof Drape FDA UDI
- Model / Reference
- 4711 FDA UDI
- Description
- Cleansing Enema Set: 1500mL Enema Bag, 60" Inlet Tubing, Tubing Clamp, Protection Clamp, Protection Cap, Castile Soap Concentrate, 45x42cm Moisture Proof Drape FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00616784471129 FDA UDI
- FDA Product Code
- FCE FDA UDI
- GMDN Term
- Manual enema device, single-use 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
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
No
FDA UDI
Category: Manual enema device, single-use
Cleansing Enema Set by Dynarex Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Manual enema device, single-use.
- McKesson — MCKESSON MEDICAL-SURGICAL 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
- Dynarex Corp.
Sources (1)
- FDA UDI 451a0934-12d5-45ff-8fc9-f7b75b7b29cf 33 fields · synced Jun 8, 2026