FDA UDI
In Commercial Distribution
🇺🇸 United States
P&P Medical Surgical LLC
DI: G026020001
·
Model: 02000
·
P&P Medical Surgical LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- P&P Medical Surgical LLC
- Primary DI
- G026020001
- Version / Model
- 02000
- Company Name
- P&P Medical Surgical LLC
- Labeler DUNS
- 022925151
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-02-10
- Public Version
- 1
- Public Version Date
- 2022-02-18
- Public Version Status
- New
- Public Device Record Key
- ae039542-60c8-46d9-8dcf-71c536114d84
Device Description
Disposable Probe Covers Lens Filters Made of Closed-Cell Foam Laminated with Sheet of High Density Polyethylene Plastic Film Fit Electronic Thermometer Box of 200
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Safe
- Direct Marking Exempt
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KGX | Tape And Bandage, Adhesive | General Hospital | 880.5240 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 13116 | Electronic thermometer probe cover | A device intended to be used as a physical barrier between the patient and the probe of a thermometer that uses electronics to create the measurement, e.g., a tympanic (in-the-ear) or electronic (body) thermometer, to prevent cross-contamination between patients. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | G026020001 | HIBCC |