FDA UDI
In Commercial Distribution
🇺🇸 United States
Dale IV Armor
DI: H84106751
·
Model: 675
·
Dale Medical Products, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Dale IV Armor
- Primary DI
- H84106751
- Version / Model
- 675
- Catalog Number
- 675
- Company Name
- Dale Medical Products, Inc.
- Labeler DUNS
- 001061233
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-09-17
- Public Version
- 4
- Public Version Date
- 2024-04-22
- Public Version Status
- Update
- Public Device Record Key
- b57803ac-f8f1-4054-a9aa-7fa19bc579bd
Device Description
Dale IV Armor, Flexible protective overlay, Fits most.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- 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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| KGX | Tape And Bandage, Adhesive | General Hospital | 880.5240 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62997 | Wearable percutaneous catheter/tube holder, non-sterile | A non-sterile device designed to fix a percutaneous catheter, tube, and/or drain (e.g., IV, epidural, or drainage catheter, GI tube) to a patient's body without suturing; it may in addition be intended for holding a non-surgically-invasive tube (e.g., nasogastric tube) to the patient (universal holder). It is designed as an adhesive pad, strip, or bandage that will attach to the patient's skin, sometimes with the exposed side having an integrated fixation mechanism (e.g., Velcro hook/loop closure) or a mechanical closure, to hold the catheter/tube in place. It may include transparent film for fixation site monitoring but it is not a film dressing. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | H84106752 | HIBCC | Box | 10 | In Commercial Distribution | |
| Primary | H84106751 | HIBCC |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Cool dry place