Identity
- Trade Name
- EXACTAMED FDA UDI
- Generic Name
- ENFit oral/enteral syringe, single-use FDA UDI
- Device Name
- Oral Dispenser Clear 0.5 mL Pharmacy Pack FDA UDI
- Model / Reference
- H9387100 FDA UDI
- Description
- Oral Dispenser Clear 0.5 mL Pharmacy Pack FDA UDI
Identifiers
- Catalog Number
- H9387100 FDA UDI
- Primary DI / UDI-DI
- 00085412494074 FDA UDI
- FDA Product Code
- KYX FDA UDI
- GMDN Term
- ENFit oral/enteral syringe, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6430 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
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 0.5 Milliliter FDA UDI
Category: ENFit oral/enteral syringe, single-use
Exactamed by Baxter Healthcare Corp — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as ENFit oral/enteral syringe, single-use.
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- VYGON — Vygon Corp. · Class II
- BD UniVia — BECTON DICKINSON AND COMPANY · Class II
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
- Baxter Healthcare Corp
Sources (1)
- FDA UDI e108accb-6be6-41bc-bd6e-cacab5da0ca2 36 fields · synced Jun 1, 2026