FDA UDI
In Commercial Distribution
🇺🇸 United States
CONVERTORS
DI: 10630140942679
·
Model: D1003
·
Cardinal Health 200, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- CONVERTORS
- Primary DI
- 10630140942679
- Version / Model
- D1003
- Catalog Number
- D1003
- Company Name
- Cardinal Health 200, LLC
- Labeler DUNS
- 961027315
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-07-08
- Public Version
- 4
- Public Version Date
- 2020-11-24
- Public Version Status
- Update
- Public Device Record Key
- c291b8d4-afff-4804-a75e-5dca41484f11
Device Description
Isolation Bag
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KGY | BAG, INTESTINE | General, Plastic Surgery | 878.4100 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33522 | Intraoperative procedure bag | A sterile flexible container used to temporarily isolate a patient body part/organ during a surgical procedure, typically to segregate it from the surgical site. The device may be used to: 1) cover a dirty body part (e.g., hand/foot) to prevent cross-contamination with the surgical site; 2) cover a clean body part (e.g., hand/foot) while performing surgery on another site (e.g., leg/knee); 3) retain organs during abdominal surgery; or 4) keep organs (e.g., intestines) moist during surgery. It is typically made of a soft, strong, clear plastic film with a seamless bottom and draw strings at the opening to create a seal around the chosen body part/organ. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50630140942677 | GS1 | CASE | 10 | In Commercial Distribution | |
| Primary | 10630140942679 | GS1 |