FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Large Volume Paracentesis Kit
DI: 00893029002007
·
Model: GIS-28
·
GI Supply, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Large Volume Paracentesis Kit
- Primary DI
- 00893029002007
- Version / Model
- GIS-28
- Catalog Number
- GIS-28
- Company Name
- GI Supply, Inc.
- Labeler DUNS
- 160990313
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 5
- Public Version Date
- 2021-07-07
- Public Version Status
- Update
- Public Device Record Key
- e90af11a-1fc1-4e93-8a79-75ad64feaa5c
- Distribution End Date
- 2018-08-03
Device Description
The GI Supply Large Volume Paracentesis Kit
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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 |
|---|---|---|---|---|
| LRO | General Surgery Tray (Kit) | General, Plastic Surgery | 878.4370 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33403 | Pleurocentesis/paracentesis kit | A collection of sterile surgical devices intended for acute (i.e., non-indwelling) therapeutic or diagnostic aspiration of fluids or air from the pleural and/or peritoneal cavities. It includes a dedicated needle, syringe, and appropriate support devices (e.g., dressings, drapes); it does not include a drainage catheter and does not contain pharmaceuticals. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10893029002004 | GS1 | Box | 5 | Not in Commercial Distribution | 2018-08-03 |
| Primary | 00893029002007 | GS1 |
Customer Contacts
- Phone
- 800-451-5797
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K970187 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 20 – 25 Degrees Celsius