Identity
- Trade Name
- CathGrip FDA UDI
- Generic Name
- Wearable percutaneous catheter/tube holder FDA UDI
- Device Name
- CathGrip Oval, Small, Non-Sterile, No Alcohol, Canada FDA UDI
- Model / Reference
- 54002NSNACA FDA UDI
- Description
- CathGrip Oval, Small, Non-Sterile, No Alcohol, Canada FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00653599002148 FDA UDI
- FDA Product Code
- KMK FDA UDI
- GMDN Term
- Wearable percutaneous catheter/tube holder FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.5210 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
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
No
FDA UDI
Category: Wearable percutaneous catheter/tube holder
CathGrip by Argentum Medical, Llc — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Wearable percutaneous catheter/tube holder.
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- Cook — COOK INCORPORATED · Class I
- Grip-Lok — TIDI PRODUCTS, LLC · Class I
- POWERWAND — Access Scientific, Inc. · Class I
- Grip-Lok — TIDI PRODUCTS, LLC · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Argentum Medical, Llc
Sources (2)
- FDA UDI 1520b6ad-83f7-420c-8d60-7bf9012b0af5 35 fields · synced Jun 20, 2026
- EUDAMED 1 fields · synced Jun 1, 2026