FDA UDI
Not in Commercial Distribution
🇺🇸 United States
ERBE
DI: 04050147020535
·
Model: 20325-239
·
Erbe Elektromedizin GmbH
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- ERBE
- Primary DI
- 04050147020535
- Version / Model
- 20325-239
- Catalog Number
- 20325-239
- Company Name
- Erbe Elektromedizin GmbH
- Labeler DUNS
- 316116623
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-01-17
- Public Version
- 6
- Public Version Date
- 2023-09-21
- Public Version Status
- Update
- Public Device Record Key
- eb7aca8f-d7f2-4911-a1f4-2efb68e3af55
- Distribution End Date
- 2023-09-20
Device Description
Hybrid CO2 Tubing/Cap Set for Olympus® Scopes & CO2 Source
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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FEQ | PUMP, AIR, NON-MANUAL, FOR ENDOSCOPE | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60738 | Endoscopic insufflation tubing set, single-use | A collection of flexible tubing intended to channel medical gas [e.g., carbon dioxide (CO2), medical air] from its source into a body cavity for insufflation during endoscopy (e.g., gastrointestinal endoscopy, laparoscopy, arthroscopy). It includes synthetic polymer tubing and associated connectors; it may in addition be intended for endoscopic lens drying, and may include additional tubing for delivery of a sterile irrigation solution for endoscopic irrigation. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 04050147020634 | GS1 | Level: 2 | 3 | Not in Commercial Distribution | 2023-09-20 |
| Package | 04050147020627 | GS1 | Level: 1 | 10 | Not in Commercial Distribution | 2023-09-20 |
| Primary | 04050147020535 | GS1 |
Customer Contacts
- Phone
- +4970717550
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K162152 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 3.500 | Meter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from heat and direct sunlight