Coulmed
- Primary DI
- 10810087350076
- Brand
- Coulmed
- Company
- Coulmed Products Group LLC
- Model
- DI-5419
- Catalog number
- DI-5419
- Device description
- "Covex Sterile C-Arm Drape with Elastic Bands: 41"" x 74"""
- Published
- 2023-01-06
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Sterile
- true
- Single use
- true
Product Codes#
| Code | Name |
|---|---|
| PUI | Drape, surgical, exempt |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| PUI | Drape, Surgical, Exempt | General, Plastic Surgery | 2 |
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 30810087350070 | Package | GS1 | 20 | In Commercial Distribution |
| 10810087350076 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized |
|---|---|
| 30810087350070 | 30810087350070 |
| 10810087350076 | 10810087350076 |
GMDN Terms#
| Term | Definition |
|---|---|
| Medical equipment/instrument drape, single-use | A flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment/instrument (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the equipment/instrument from soiling and/or contamination when used inside, or within the vicinity of, a hygienic area; it may have patient contact, however it is not intended to be introduced into a body cavity (noninvasive). It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device. |
Regulatory Flags#
- DUNS number
- 047115479
- Device count
- 1
- Premarket exempt
- true
- Lot or batch
- true
- Expiration date on label
- true
- No natural rubber latex
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 10810087352605 | Coulmed | AC28-P | AC28-P | 2023-01-06 |
| 10810087352612 | Coulmed | AC3300-BP | AC3300-BP | 2023-01-06 |
| 10810087352629 | Coulmed | AC3400-BP | AC3400-BP | 2023-01-06 |
| 10810087352636 | Coulmed | AC3800-BP | AC3800-BP | 2023-01-06 |
| 10810087352643 | Coulmed | AC3800-BP-L | AC3800-BP-L | 2023-01-06 |
| 10810087352650 | Coulmed | AC3800-BP-R | AC3800-BP-R | 2023-01-06 |
| 10810087352667 | Coulmed | AC3900-BP | AC3900-BP | 2023-01-06 |
| 10810087350007 | Coulmed | DI-5403 | DI-5403 | 2023-01-06 |
| 10810087350014 | Coulmed | DI-5404 | DI-5404 | 2023-01-06 |
| 10810087350021 | Coulmed | DI-5406 | DI-5406 | 2023-01-06 |
| 10810087350038 | Coulmed | DI-5408 | DI-5408 | 2023-01-06 |
| 10810087350045 | Coulmed | DI-5414 | DI-5414 | 2023-01-06 |
| 10810087350052 | Coulmed | DI-5415 | DI-5415 | 2023-01-06 |
| 10810087350069 | Coulmed | DI-5416 | DI-5416 | 2023-01-06 |
| 10810087350083 | Coulmed | DI-5420 | DI-5420 | 2023-01-06 |
| 10810087350090 | Coulmed | DI-5424 | DI-5424 | 2023-01-06 |
| 10810087350106 | Coulmed | DI-5503 | DI-5503 | 2023-01-06 |
| 10810087350113 | Coulmed | DI-6101 | DI-6101 | 2023-01-06 |
| 10810087350120 | Coulmed | DI-6102 | DI-6102 | 2023-01-06 |
| 10810087350137 | Coulmed | DI-6103 | DI-6103 | 2023-01-06 |
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