Henry Schein
- Primary DI
- 10304040134396
- Brand
- Henry Schein
- Company
- HENRY SCHEIN, INC.
- Model
- 5702140
- Catalog number
- 5702140
- Device description
- Reusable Cold and Hot Gel Pack
- Published
- 2020-09-10
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- true
- Sterile
- false
- Single use
- false
Related Records
Product Codes
| Code | Name |
|---|---|
| IME | Pack, hot or cold, reusable |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| IME | Pack, Hot Or Cold, Reusable | Physical Medicine | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 10304040134396 | Package | GS1 | 100 | In Commercial Distribution |
| 00304040134382 | Primary | GS1 | 0 | |
| 00304040134399 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 10304040134396 | 10304040134396 | ||
| 00304040134382 | 00304040134382 | 304040134382 | 0304040134382 |
| 00304040134399 | 00304040134399 | 304040134399 | 0304040134399 |
GMDN Terms
| Term | Definition |
|---|---|
| Ice bag | A flexible container (a bag) designed to be filled with ice to provide dry cold therapy to a limited external surface area of the body. It is typically made of plastic or rubber materials with a detachable cap that can be threaded or fixed to the bag once it is filled with ice. It may include a holder or attachments to facilitate fixing or holding the device in place against the body surface of the patient. It can be used to alleviate pain and/or promote healing in minor injuries of the body, e.g., after minor surgery, bruises, tissue swelling, or for application around the neck or limbs. This is a reusable device. |
Sterilization Methods
| Method |
|---|
Regulatory Flags
- DUNS number
- 012430880
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- false
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- true
- Sterilization required before use
- false
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| 00304040195437 | Henry Schein | 5705824 | 5705824 | 2026-03-17 |
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| 00304040187647 | Zirlux | 9200063 | 9200063 | 2026-02-04 |
| 00304040187654 | Zirlux | 9200064 | 9200064 | 2026-02-04 |
| 00304040187661 | Zirlux | 9200065 | 9200065 | 2026-02-04 |
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