Identity
- Trade Name
- Passport FDA UDI
- Generic Name
- Gastrostomy button FDA UDI
- Device Name
- Passport Patient Care Kit FDA UDI
- Model / Reference
- G22615 FDA UDI
- Description
- Passport Patient Care Kit FDA UDI
Identifiers
- Catalog Number
- PASS-PCK-I FDA UDI
- Primary DI / UDI-DI
- 00827002226159 FDA UDI
- FDA Product Code
- KNT FDA UDI
- GMDN Term
- Gastrostomy button FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5980 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Passport by Cook Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 II | Pending data |
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Manufacturer
- Manufacturer
- Cook Incorporated
Sources (1)
- FDA UDI bf695fbc-c6a7-4289-b44a-6d99cf439c3c 37 fields · synced Jun 6, 2026