FDA UDI
In Commercial Distribution
🇺🇸 United States
APK
DI: 06946725503164
·
Model: I-DLP-05BU-40AS-0100
·
APK Technology Co.,Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- APK
- Primary DI
- 06946725503164
- Version / Model
- I-DLP-05BU-40AS-0100
- Company Name
- APK Technology Co.,Ltd.
- Labeler DUNS
- 529691989
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-07-22
- Public Version
- 1
- Public Version Date
- 2025-07-30
- Public Version Status
- New
- Public Device Record Key
- dca457ae-087e-4092-afd3-3e5f9cab365a
Device Description
LDW DISP ECG LW, 5LD, PINCH TO COMPATIBLE PHILIPS INTELLIVUE, W/ SHOWER SHIELD
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
- 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
- Yes
- 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 |
|---|---|---|---|---|
| DSA | Cable, Transducer And Electrode, Patient, (Including Connector) | Cardiovascular | 870.2900 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61821 | Electrocardiographic lead set, single-use | A collection of noninvasive devices intended to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine or a patient monitoring system. It is designed as an insulated wire(s), which may additionally include a detachable or permanently attached electrode and/or cable with connector. Some types may be designed as a pre-configured array to assist electrode placement. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 16946725503161 | GS1 | 10 | In Commercial Distribution | ||
| Primary | 06946725503164 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K170536 | 000 |