FDA UDI
In Commercial Distribution
🇺🇸 United States
Zammi
DI: 07899043000039
·
Model: 11102E
·
Zammi Instrumental Eireli
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Zammi
- Primary DI
- 07899043000039
- Version / Model
- 11102E
- Catalog Number
- 11102E
- Company Name
- Zammi Instrumental Eireli
- Labeler DUNS
- 898759832
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-03-09
- Public Version
- 1
- Public Version Date
- 2023-03-17
- Public Version Status
- New
- Public Device Record Key
- f51ba662-483e-48b2-a464-988a0c5445b0
Device Description
ONE-WAY VALVE CHEST DRAINAGE SYSTEM - PHYSIODRAIN 1000 ml
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| KDQ | Bottle, Collection, Vacuum | General Hospital | 880.6740 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35824 | Closed-wound drainage kit | A collection of devices designed to remove fluids or purulent material from a closed-wound in a controlled manner. It includes a container (the receptacle or reservoir), drains/catheters, connectors, a grasping device and possibly a trocar for placing the drains/catheters into the site. The reservoir will usually be provided with graduated markers along its side to facilitate the approximate measurement of the collected fluids. This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07899043000039 | GS1 |