FDA UDI
In Commercial Distribution
🇺🇸 United States
Pediatric-Pak
DI: 05060167120473
·
Model: Pad-Pak-02
·
HEARTSINE TECHNOLOGIES LTD
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Pediatric-Pak
- Primary DI
- 05060167120473
- Version / Model
- Pad-Pak-02
- Catalog Number
- PAD-PAK-02
- Company Name
- HEARTSINE TECHNOLOGIES LTD
- Labeler DUNS
- 230479318
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-08-20
- Public Version
- 2
- Public Version Date
- 2023-07-06
- Public Version Status
- Update
- Public Device Record Key
- e06bc86c-25d8-4fb0-8728-b9e3bafaaa52
Device Description
Battery and Electrode Cartridge
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MKJ | Automated external defibrillators (non-wearable) | Cardiovascular | 870.5310 | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47912 | Non-rechargeable public semi-automated external defibrillation electrode, paediatric | An electrical conductor, with integral batteries and regulated by a dedicated external pulse generator (EPG), designed to create an electrical shock(s) and defibrillate the heart (restore normal rhythm) to treat ventricular fibrillation or pulseless ventricular tachycardia in a pre-pubescent patient. It is a cartridge-type electrode, in pairs, with non-rechargeable batteries that provide the energy to produce the electrical shock(s) after its adhesive pads are placed on the skin of the patient. This is a single-use device that is replaced after a patient application or after elapse of its expiry date. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Previous | M727PADPAK02 | HIBCC | ||||
| Primary | 05060167120473 | GS1 |
Customer Contacts
- Phone
- +1(215)860-8100
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P160008 | 008 |
| P160008 | 009 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 50 Degrees Celsius
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 57.2 – 106 KiloPascal
- Type
- Handling Environment Humidity
- Temperature Range
- 5 – 95 Percent (%) Relative Humidity
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 57.2 – 106 KiloPascal
- Type
- Handling Environment Temperature
- Temperature Range
- 0 – 50 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- DO NOT STORE the Pediatric-Pak next to magnetically sensitive storage media as it contains a magnetic component (surface strength 6500 gauss).
- Type
- Storage Environment Humidity
- Temperature Range
- 5 – 95 Percent (%) Relative Humidity