Feel Ject(FIS-212, U-100, 1.0cc, 30G x 8mm)

GUDID 08800045105478

Feel Tech Bio Co., Ltd.

Insulin syringe/needle, basic

• Primary Device ID: 08800045105478
• NIH Device Record Key: 0d4d330c-82ae-4c2a-9606-0e4147498b5d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Feel Ject(FIS-212, U-100, 1.0cc, 30G x 8mm)
• Version Model Number: FIS-212
• Company DUNS: 694632098
• Company Name: Feel Tech Bio Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800045105461 [Primary]
GS1	08800045105478 [Package]; Contains: 08800045105461; Package: INBOX [100 Units]; In Commercial Distribution
GS1	08800045107403 [Package]; Package: CARTONBOX [3000 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070917

FDA Product Code

• FMF: Syringe, Piston

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-02-16
• Device Publish Date: 2026-02-06

Devices Manufactured by Feel Tech Bio Co., Ltd.

• 08800045101906 - Feel Ject(FIS-019, U-100, 0.3cc, 32G x 8mm): 2026-02-16
• 08800045102057 - Feel Ject(FIS-024, U-100, 0.5cc, 32G x 8mm): 2026-02-16
• 08800045102200 - Feel Ject(FIS-029, U-100, 1.0cc, 32G x 8mm): 2026-02-16
• 08800045102538 - Feel Ject(FIS-039, U-100, 0.3cc, 31G x 6mm): 2026-02-16
• 08800045105201 - Feel Ject(FIS-203, U-100, 0.3 cc, 30G x 12.7mm): 2026-02-16
• 08800045105232 - Feel Ject(FIS-204, U-100, 0.3cc, 30G x 8mm): 2026-02-16
• 08800045105478 - Feel Ject(FIS-212, U-100, 1.0cc, 30G x 8mm): 2026-02-16
• 08800045105478 - Feel Ject(FIS-212, U-100, 1.0cc, 30G x 8mm): 2026-02-16
• 08800045105652 - Feel Ject(FIS-2502, U-100, 0.5 cc, 30G x 8mm): 2026-02-16