FDA UDI
In Commercial Distribution
🇺🇸 United States
GLOBAL HEALTHCARE
DI: 00872237005246
·
Model: 60-T01
·
GHC HEALTHCARE, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- GLOBAL HEALTHCARE
- Primary DI
- 00872237005246
- Version / Model
- 60-T01
- Company Name
- GHC HEALTHCARE, INC.
- Labeler DUNS
- 884718776
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-02-10
- Public Version
- 5
- Public Version Date
- 2020-12-04
- Public Version Status
- Update
- Public Device Record Key
- 94fec1fc-9045-4e88-ac58-d47b83f260a3
Device Description
UNIVERSAL CATHETERIZATION TRAY. CONTENTS: DRAINAGE BAG 2000CC, SYRINGE 10CC PRE-FILLED W/ STERILE WATER, COTTON BALLS (6), VINYL GLOVES (2), DRAPE, FENESTRATED DRAPE, CATHETER LUBRICATING JELLY, POVIDONE-IODINE SOLUTION, SPECIMEN CONTAINER 2oz, PATIENT LABEL, FORCEPS, WRAP.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- Yes
- 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
- 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 |
|---|---|---|---|---|
| FCM | Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) | Gastroenterology, Urology | 876.5130 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61355 | Urethral catheterization support kit, urinary drainage | A collection of non-surgically invasive devices intended to assist a healthcare professional to insert a urethral catheter (not included) into the urinary bladder, typically for drainage of urine; some types may also be intended for catheter removal. It typically includes forceps, dressings, gloves, and drapes; it does not include 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 | 40872237005244 | GS1 | CASE | 10 | In Commercial Distribution | |
| Primary | 00872237005246 | GS1 |