FDA UDI
In Commercial Distribution
🇺🇸 United States
Marcon
DI: 00827002222182
·
Model: G22218
·
COOK IRELAND LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Marcon
- Primary DI
- 00827002222182
- Version / Model
- G22218
- Catalog Number
- CDSM-10
- Company Name
- COOK IRELAND LTD
- Labeler DUNS
- 988559035
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 3
- Public Version Date
- 2020-03-24
- Public Version Status
- Update
- Public Device Record Key
- d6e697de-fb86-4969-9680-b4ab9943ff48
Device Description
Marcon Colon Decompression Set
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
- No
- MRI Safety
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- No
- 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 |
|---|---|---|---|---|
| FEG | TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION | Gastroenterology, Urology | 876.5980 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61910 | Colonic decompression tube | A sterile, thin, flexible, hollow cylinder intended to be used to mechanically decompress the colon, typically by connection to an intermittent suction system, to treat conditions including non-toxic megacolon, pseudo-obstruction (Ogilvie syndrome) and/or colonic strictures. It includes a guidewire which is inserted per rectum using a colonoscope (not included) under fluoroscopic assistance. It is made of plastic and rubber materials and may be a straight or pigtail tube with drainage bag connectors/adaptors at the proximal end. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00827002222182 | GS1 |
Customer Contacts
- Phone
- +1(812)330-5494
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in a dry location, away from temperature extremes