FDA UDI
In Commercial Distribution
🇺🇸 United States
HeartStart
DI: 00884838035256
·
Model: CPR Meter Patient Adhesive Pads
·
PHILIPS ELECTRONICS NORTH AMERICA CORPORATION
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
Basic Information
- Brand Name
- HeartStart
- Primary DI
- 00884838035256
- Version / Model
- CPR Meter Patient Adhesive Pads
- Catalog Number
- 989803163291
- Company Name
- PHILIPS ELECTRONICS NORTH AMERICA CORPORATION
- Labeler DUNS
- 079503890
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2016-12-07
- Public Version
- 6
- Public Version Date
- 2023-08-01
- Public Version Status
- Update
- Public Device Record Key
- fe479606-09ec-41b1-84c6-d7c878fb6410
Device Description
CPR meter adhesives, 10 pack
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
- No
- 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 |
| DRO | Pacemaker, Cardiac, External Transcutaneous (Non-Invasive) | Cardiovascular | 870.5550 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16866 | Dressing-fixation skin adhesive tape, non-silicone | A long and narrow flexible band of non-silicone-based material (e.g., fabric, plastic, paper) coated on one or both sides with a pressure-sensitive adhesive, intended to non-invasively adhere to the skin surface to fix a dressing in place or attach objects (e.g., catheter, lamp); it might have hypoallergenic and/or waterproof properties. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00884838035256 | GS1 | ||||
| Unit of Use | 00884838116689 | GS1 |
Customer Contacts
- Phone
- +1(999)999-9999
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 12 – 35 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 0 – 95 Percent (%) Relative Humidity