FDA UDI
Not in Commercial Distribution
🇺🇸 United States
CrOC
DI: M68931200C0
·
Model: C
·
Safeguard US Operating, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- CrOC
- Primary DI
- M68931200C0
- Version / Model
- C
- Catalog Number
- 31-200
- Company Name
- Safeguard US Operating, LLC
- Labeler DUNS
- 118492643
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-03-23
- Public Version
- 3
- Public Version Date
- 2024-11-01
- Public Version Status
- Update
- Public Device Record Key
- eff9d74d-93ac-4981-af91-288d2b3ccc80
- Distribution End Date
- 2024-10-31
Device Description
The CRoC is indicated for use in the battlefield to control difficult bleeds in the inguinal and axilla areas. The CRoC is also indicated for use in the battlefield as a last resort for life threatening bleeds of the carotid artery.
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
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DXC | Clamp, Vascular | Cardiovascular | 870.4450 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63268 | Emergency junctional haemorrhage compression set | A collection of non-sterile, noninvasive devices intended to be used in an emergency situation (e.g., battlefield) to provide compression for haemostasis to a traumatic wound occurring proximal to where a limb meets the torso/pelvis. Often referred to as a junctional tourniquet, it consists of a belt(s)/binder(s), an inflatable bulb(s), and a hand pump. The inflatable bulb is intended to be secured at the point of the wound with the belt, then inflated to provide compression and prevent bleeding. The belt component may be additionally intended to be used as a binder. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M68931200C0 | HIBCC |