FDA UDI
In Commercial Distribution
🇺🇸 United States
Silicone tubing ID 6.5mm, 180cm, 1 coupling piece
DI: 07612367000109
·
Model: 077.0961
·
Medela AG
Product Codes
4
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Silicone tubing ID 6.5mm, 180cm, 1 coupling piece
- Primary DI
- 07612367000109
- Version / Model
- 077.0961
- Company Name
- Medela AG
- Labeler DUNS
- 488293218
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-05-31
- Public Version
- 2
- Public Version Date
- 2025-11-06
- Public Version Status
- Update
- Public Device Record Key
- cce6caec-1355-47e3-96b5-13c5912fddf0
Device Description
Silicone tubing ID 6.5mm, 180cm, 1 coupling piece
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
- 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 |
|---|---|---|---|---|
| BTA | Pump, Portable, Aspiration (Manual Or Powered) | General, Plastic Surgery | 878.4780 | 2 |
| QPB | System, Suction, Lipoplasty For Removal | General, Plastic Surgery | 878.5040 | 2 |
| MUU | System, Suction, Lipoplasty | General, Plastic Surgery | 878.5040 | 2 |
| HDB | Extractor, Vacuum, Fetal | Obstetrics/Gynecology | 884.4340 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 42834 | Vacuum hose | A length of reinforced colour-coded flexible tubing intended to be connected to a vacuum-producing medical device, medical equipment, or a medical system to channel incoming suction. It has a thick wall to prevent collapse due to the negative pressure of the vacuum and typically produced according to ISO5359. It is available in various lengths, including standard coil lengths. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07612367000109 | GS1 |
Customer Contacts
- Phone
- +1-877-735-1626
- [email protected]