FDA UDI
In Commercial Distribution
🇺🇸 United States
CrocClamp™ (Non-Reopening Clamp)
DI: 19555240400960
·
Model: A100111
·
ITL ASIA PACIFIC SDN. BHD.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
4000
Basic Information
- Brand Name
- CrocClamp™ (Non-Reopening Clamp)
- Primary DI
- 19555240400960
- Version / Model
- A100111
- Catalog Number
- A100111
- Company Name
- ITL ASIA PACIFIC SDN. BHD.
- Labeler DUNS
- 597723837
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 4000
- Record Status
- Published
- Publish Date
- 2020-09-20
- Public Version
- 1
- Public Version Date
- 2020-09-28
- Public Version Status
- New
- Public Device Record Key
- 02ab0659-e442-412a-bf6f-031fa94fdbe4
Device Description
CrocClamp™ (Non-Reopening Clamp) is a device that permanently and completely occludes the tubing fluid path.
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
- 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
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KSD | Device, Heat-Sealing | Hematology | 864.9750 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62454 | Medical tubing clip/clamp, permanent | A non-sterile, small, metallic or plastic, clip-like device designed to irreversibly (permanently) compress a piece of medical device tubing to occlude its lumen and stop the flow of material within; it is not intended for patient-contact. It is intended to be compressed onto the tubing and retain its compressed form. It may be referred to as a clip or a clamp. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 19555240400960 | GS1 | ||||
| Unit of Use | 09555240400963 | GS1 |
Customer Contacts
- Phone
- +18884112851
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep Dry
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep Away from Direct Sunlight