FDA UDI
Not in Commercial Distribution
🇺🇸 United States
AnesthesiaSet Flex Latexfrei US
DI: 04048675126317
·
Model: MP00323
·
Drägerwerk AG & Co. KGaA
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
25
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Basic Information
- Brand Name
- AnesthesiaSet Flex Latexfrei US
- Primary DI
- 04048675126317
- Version / Model
- MP00323
- Company Name
- Drägerwerk AG & Co. KGaA
- Labeler DUNS
- 315578914
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 25
- Record Status
- Published
- Publish Date
- 2015-10-24
- Public Version
- 5
- Public Version Date
- 2026-02-03
- Public Version Status
- Update
- Public Device Record Key
- cd020f61-e5b7-481f-b8bf-d543e4c5b35a
- Distribution End Date
- 2016-08-02
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 Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| BTC | Bag, Reservoir | Anesthesiology | 868.5320 | 1 |
| CAI | Circuit, Breathing (W Connector, Adaptor, Y Piece) | Anesthesiology | 868.5240 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37704 | Anaesthesia breathing circuit, single-use | An assembly of devices designed to conduct medical gases from an anaesthesia unit/workstation to a patient artificial airway/anaesthesia mask (not included) during general anaesthesia. It includes breathing tubes and a Y-piece connector, typically with a ventilator/ventilation bag and appropriate connectors, and may include a carbon dioxide (CO2) absorber, a one-way directional valve, or adjustable pressure limiting (APL) valve. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04048675126317 | GS1 | ||||
| Unit of Use | 04048675422259 | GS1 |
Customer Contacts
- Phone
- +494518820
- [email protected]