FDA UDI
In Commercial Distribution
🇺🇸 United States
HeartStart
DI: 00884838003316
·
Model: Switched Int Pdl Adapter
·
Philips Medical Systems Hsg
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- HeartStart
- Primary DI
- 00884838003316
- Version / Model
- Switched Int Pdl Adapter
- Catalog Number
- M4740A
- Company Name
- Philips Medical Systems Hsg
- Labeler DUNS
- 790605856
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-01-31
- Public Version
- 3
- Public Version Date
- 2023-03-28
- Public Version Status
- Update
- Public Device Record Key
- 58a5b89e-39f5-4948-9c6a-b5bf7e03aa71
Device Description
HS Switchless Int Pdl Adapter
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LDD | Dc-Defibrillator, Low-Energy, (Including Paddles) | Cardiovascular | 870.5300 | 2 |
| MKJ | Automated external defibrillators (non-wearable) | Cardiovascular | 870.5310 | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35041 | Electrosurgical cable adaptor | A small connector used to join the cable(s) from a handpiece/electrode(s) (active and/or return) to the generator of an electrosurgical system. This device will typically be used when the system components are from different manufacturers and the connections are not compatible. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00884838003316 | GS1 |
Customer Contacts
- Phone
- +1(999)999-9999
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 70 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- -4 – 158 Degrees Fahrenheit
- Type
- Storage Environment Humidity
- Temperature Range
- 5 – 95 Percent (%) Relative Humidity