FDA UDI
Not in Commercial Distribution
🇺🇸 United States
n.a.
DI: 04250105612936
·
Model: 30-55-501
·
VBM Medizintechnik GmbH
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- n.a.
- Primary DI
- 04250105612936
- Version / Model
- 30-55-501
- Company Name
- VBM Medizintechnik GmbH
- Labeler DUNS
- 324869601
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-08-31
- Public Version
- 2
- Public Version Date
- 2022-02-10
- Public Version Status
- Update
- Public Device Record Key
- 583b00d4-70fc-4909-a161-f720ebbf3ad8
- Distribution End Date
- 2022-02-09
Device Description
Manual Suction Pump
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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- Yes
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GCY | Apparatus, Suction, Single Patient Use, Portable, Nonpowered | General, Plastic Surgery | 878.4680 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47368 | Emergency airway clearance suction system, manual | A portable assembly of devices, which includes a non-surgical invasive component, intended to manually aspirate unwanted materials (e.g., fluids, secretions) from the airway typically during patient transport or an emergency situation (e.g., placed on a crash cart). It includes a manually-powered (hand or foot-operated) suction pump, a collection container, and patient contact devices (e.g., handpiece/tip, mask), and typically also contains tubing and microbial/hydrophobic filters. The system is not intended for surgical use. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 14250105612933 | GS1 | 1 | Not in Commercial Distribution | 2022-02-09 | |
| Primary | 04250105612936 | GS1 |
Customer Contacts
- Phone
- +49745495960
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Pump olive coloured ; Canister: 1x 50 ml / 1x 250 ml ; Suction Catheter: 1x 14 Fr / 1x 28 Fr / 1x 36 Fr ; Suction Cap: 1x ; Catheter Adapter: 1x |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- keep dry, keep away from sunlight and heat