FDA UDI
In Commercial Distribution
🇺🇸 United States
Cardinal Health
DI: 00748426123568
·
Model: Organ Bag
·
Microtek Medical LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- Cardinal Health
- Primary DI
- 00748426123568
- Version / Model
- Organ Bag
- Catalog Number
- 29-10039
- Company Name
- Microtek Medical LLC
- Labeler DUNS
- 106908437
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-09-26
- Public Version
- 3
- Public Version Date
- 2025-02-05
- Public Version Status
- Update
- Public Device Record Key
- 765ff6b0-0d00-421d-9a8e-dffc891ef19c
Device Description
ISOLATION BAG 18X18.5IN CARDINAL
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
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Ethylene Oxide
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 | 30748426123569 | GS1 | 10 | In Commercial Distribution | ||
| Primary | 00748426123568 | GS1 | ||||
| Package | 50748426123563 | GS1 | 1 | In Commercial Distribution |
Customer Contacts
- Phone
- 1-800-824-3027
- [email protected]