Identity
- Trade Name
- Certa Dose PALS Syringe Holder FDA UDI
- Generic Name
- Syringe/ampule clip FDA UDI
- Device Name
- A small device intended to be used to clip to the syringe used to withdraw the medication it contained, during the administration of medication to a patient, in order to identify the type of medication in the syringe to help prevent the misadministration of the medication. It is made of plastic material and designed to be clipped to the base of either a Luer or a Luer-lock syringe. It is typically used by ambulance paramedics, personnel in accident and emergency (A&E) rooms. This is a single-use device FDA UDI
- Model / Reference
- CD-PALS-0001 FDA UDI
- Description
- A small device intended to be used to clip to the syringe used to withdraw the medication it contained, during the administration of medication to a patient, in order to identify the type of medication in the syringe to help prevent the misadministration of the medication. It is made of plastic material and designed to be clipped to the base of either a Luer or a Luer-lock syringe. It is typically used by ambulance paramedics, personnel in accident and emergency (A&E) rooms. This is a single-use device FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860425001620 FDA UDI
- FDA Product Code
- IQG FDA UDI
- GMDN Term
- Syringe/ampule clip FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.5050 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
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Syringe/ampule clip
Certa Dose PALS Syringe Holder by CD Acquisitions, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- CD Acquisitions, LLC
Sources (1)
- FDA UDI 005e6081-f2f4-424f-a368-4deda4480ce1 34 fields · synced May 30, 2026