FDA UDI
In Commercial Distribution
🇺🇸 United States
OxiPen®
DI: 04036616000208
·
Model: incl. RM-3227
·
EnviteC-Wismar GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- OxiPen®
- Primary DI
- 04036616000208
- Version / Model
- incl. RM-3227
- Catalog Number
- 1000159
- Company Name
- EnviteC-Wismar GmbH
- Labeler DUNS
- 330943838
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-22
- Public Version
- 5
- Public Version Date
- 2021-11-10
- Public Version Status
- Update
- Public Device Record Key
- bf011688-ab0a-4761-b9dd-d93ad27d00b2
Device Description
OxiPen® incl. RM-3227
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
- Yes
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- Yes
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| DQA | Oximeter | Cardiovascular | 870.2700 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45607 | Pulse oximeter | An electrically-powered photoelectric device designed for the transcutaneous measurement and display of haemoglobin oxygen saturation (SpO2). The signals are produced by light-emitting diodes (LEDs) and received by a photodetector. The device displays the SpO2 values and may also measure/display pulse rate. It is typically applied to the fingertip or around the wrist, may be single-component (with built-in probe) or multi-component (includes external probe), and may in addition wirelessly transmit measurements to a receiving location (e.g., central station, bedside monitor); it is intended to be operated by laypersons and healthcare providers. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04036616000208 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Depth | 30 | Millimeter | |
| Height | 155 | Millimeter | |
| Length | 210 | Millimeter |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 0 – 45 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 0 – 90 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 70 Degrees Celsius