Identity
- Trade Name
- PAD 109 FDA UDI
- Generic Name
- External defibrillation electrode, adult, reusable FDA UDI
- Device Name
- HEARTSTREAM XLT WITH GRAY/FLAT FDA UDI
- Model / Reference
- PAD 109 FDA UDI
- Description
- HEARTSTREAM XLT WITH GRAY/FLAT FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00811331017700 FDA UDI
- 510(k) Number
- K983196 FDA UDI
- FDA Product Code
- DRO FDA UDI
- GMDN Term
- External defibrillation electrode, adult, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.5550 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
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: External defibrillation electrode, adult, reusable
Pad 109 by Tz Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as External defibrillation electrode, adult, reusable.
- STANDARD HARD PADDLES — PHYSIO-CONTROL, Inc. · Class III
- PEDIATRIC PADDLE, EXTERNAL — PHYSIO-CONTROL, Inc. · Class III
- ASSY, CABLE, THERAPY, LP35 — PHYSIO-CONTROL, Inc. · Class III
- STANDARD HARD PADDLES — PHYSIO-CONTROL, Inc. · Class III
- HOLDER URINE DRAINAGE BAG CANVAS — AliMed, LLC · Class I
- STANDARD HARD PADDLES — PHYSIO-CONTROL, Inc. · Class II
- Quik-Combo Therapy Cable — PHYSIO-CONTROL, Inc. · Class III
- URINE DRAIN BAG HOLD NAUGAHYDE — AliMed, LLC · Class I
Cleared under the same submission
K983196 also covers:
- PAD 101PD — Tz Medical, Inc.
- PAD 101PDL — Tz Medical, Inc.
- PAD 108 — Tz Medical, Inc.
- PAD 1110 — Tz Medical, Inc.
- PAD 1110C — Tz Medical, Inc.
- PAD 1110Z — Tz Medical, Inc.
- PAD 1111 — Tz Medical, Inc.
- PAD 1112 — Tz Medical, Inc.
- PAD 1113 — Tz Medical, Inc.
- PAD 1114 — Tz Medical, Inc.
- PAD 1115 — Tz Medical, Inc.
- PAD 1115C — Tz Medical, Inc.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Tz Medical, Inc.
Sources (1)
- FDA UDI b59daf98-9105-4714-95f1-7ea0f18822dd 34 fields · synced May 29, 2026